Ancient wisdom of ayurveda vis-à-vis contemporary aspect of materiovigilance.

Materiovigilance is regulatory system to study and follow incidents that might result from using medical devices. To trail the occurrence of untoward effects associated with medical devices as well as to document and prevent their recurrence; the Indian Pharmacopeia Commission initiated Materiovigilance program in India (MvPI) in 2015. Classical texts of Ayurveda include substantial description of devices intended for various therapeutic purposes such as Panchakarm (penta-bio purification procedures), Surgeries and for management of gynecological conditions etc. The implemented program of Materiovigilance does not include Ayurveda devices and thus there is need for documentation, systematic classification of Ayurveda devices and development of Ayurveda Materiovigilance (AMv). In this review, relevant information from classical texts of Ayurveda, latest published information related to Materiovigilance and information of medical devices from classical texts of Ayurveda has been scrutinized along with systematic correlation and applied interpretation of the collected data. It is observed that Materiovigilance has been well documented in Ayurveda in context of twenty six surgical and diagnostic devices; eleven mostly utilized pharmaceutical instruments five Panchakarma instruments and five home devices. For regulation of quality of Ayurveda medical devices, their manufacturing, standard utilization, reporting and prevention of medical device associated errors; it is the need of hour to create and implement regulation in the form of AMv. The Ayurveda literature highlights that the ancient seers of Ayurveda were well aware regarding Materiovigilance in their own way. However in view of modern era and mainstreaming of Ayurveda heritage, critical revision, updating, systematically categorization of Ayurveda devices, development and implementation of AMv regulation is the need of hour.

Knowledge, attitude and practice towards pharmacovigilance among ayurveda physicians and teachers of Gujarat State: A cross sectional study.

Aim: The aim of this study was to assess the knowledge, attitude, and practice towards pharmacovigilance for Ayurveda among the teachers and practitioners working in Ayurveda colleges of Gujarat State. Materials and Methods: A survey questionnaire with 29 questions covering points like participants' knowledge, attitude and practice towards pharmacovigilance, adverse drug reaction reporting, and misleading advertisements related Ayurveda drugs was developed in Google form format. The study was carried out during December 2020 and January 2021. Question-wise analysis was made and their percentage value was calculated with the help of a Microsoft Excel spreadsheet in MS Office 2010. The result was presented using simple frequencies with percentages in appropriate tables. Results: Results from this study show that majority of the respondents were having a good knowledge regarding the concept of pharmacovigilance and ADRs in terms of their definitions and purposes. But, a complete knowledge regarding the structure of present national and international pharmacovigilance programme, reporting the ADR and its format were still lacking among majority of the participants. An encouraging attitude towards reporting of adverse drug reaction of ASU&H drugs and teaching of Pharmacovigilance for all the healthcare professionals by majority of the participants was observed. Further maximum participants opine a mandatory rule for reporting of ADR by Physicians, Pharmacist and Nursing staff. A major part of respondents (78.03%) opine that poor quality of drug, medication errors, prescription errors, dispensing errors are part of Pharmacovigilance under drug-related problems. The observed positive attitude is not being reflected in term of practice i.e., reporting of ADR related to Ayurveda drugs. One-third of the participants reported their experience about adverse drug reactions during their professional practice, out of which very few have reported ADRs. Difficulty in deciding or identifying the ADR and lack of time to report ADR is one of the major factor discouraging the participants from reporting ADRs. A large number of respondents were also not familiar with reporting misleading advertisements. Conclusion: Findings of this study reflects a good knowledge of the participants about the concept of Pharmacovigilance but unfamiliarity about the programme. The positive attitude towards practice of Pharmacovigilance and ADR reporting can be converted to foster pharmacovigilance practice through series of awareness programmes.

A randomized open label parallel group pilot study to evaluate efficacy of Ayurveda interventions in the management of asymptomatic and mild COVID-19 patients-experiences of a Lucknow based level 2 hospital of Uttar Pradesh, India.

BACKGROUND: SARS--CoV-2 has emerged as a global threat since its onset in December 2019. India has also been severely affected by the dreadful Corona Virus and is currently battling one of the worst pandemics of history. WHO and the world medical fraternity are putting their efforts to materialize a treatment or vaccine for this novel virus. A randomized open label parallel group study was designed in a Lucknow based level 2 COVID hospital to evaluate the efficacy of Ayurvedic interventions in the management of asymptomatic and mild COVID 19 patients. OBJECTIVE: To evaluate the efficacy of Ayurveda in the management of mildly affected COVID-19 patients. MATERIALS AND METHODS: The current trial was an open label randomized 10-day study. Total 120 asymptomatic and/or mild COVID-19 positive patients fulfilling inclusion criteria were randomly grouped into three. RT-PCR of all the patients were done on 5th, 7th and on 10th day respectively. The observations were noted and results were analyzed statistically. Kruskal-Wallis test and Wilcoxon Sign rank test were used for data analysis where applicable. RESULTS: Improvement in symptoms, enhancement in Agni and recovery from COVID infection was observed. The results obtained were encouraging and showed better viral clearance and control of symptom progression in the patients placed on Ayurvedic medications. CONCLUSION: The promising results in the study showed that an approach involving Ayurveda can be helpful for the management of the mild COVID-19 patients. Ayurveda can be used to limit community spread and check disease progression to a more appalling state. TRIAL REGISTRATION: Trial was registered with Clinical Trials Registry- India (CTRI registration number: CTRI/2020/06/025800.

Personalized ayurvedic approach involving Sadyo Vamana in COVID-19 management: A case report.

Sars Cov-2 has emerged as a global threat worldwide. At present, India is the second worsely-hit nation by COVID-19. Since it is a novel virus, there is no specific treatment strategy available at present. A mild symptomatic case of COVID-19 was managed through Ayurvedic intervention involving a personalized approach based on his Prakruti. He was prescribed Vamana Karma followed by Vyaghryadi Kashaya as an oral drug for fifteen days. The patient recovered well clinically, the disease progression to a more severe stage was not observed and the patient tested negative for COVID on the 17th day. In this report, the patient was of Kapha predominant Prakruti and his strength was good so he was prescribed Vamana Karma. Ayurveda advocates patient management by incorporating personal physical and mental attributes classified as Doshas. The promising results in the present case study indicate that a personalized approach involving Ayurveda in such cases can be helpful for a better prognosis.

Patterns of concomitant use of Ayurveda and conventional anti-diabetic formulations - Experiences at a tertiary care Ayurveda hospital, India.

BACKGROUND: Majority of the population relies on traditional medicines for many of their health related problems. Particularly individuals with chronic illness like diabetes mellitus (DM) are more likely to simultaneously use herbal medicines. Many of such users believe that traditional medicines are natural and therefore safe, but this is a dangerous over simplification. Some herbal medicines may be associated with adverse effects, which include interactions with prescribed drugs. Information on such concomitant use of anti-diabetic drugs along with Ayurveda medicines is limited in Indian scenario. AIMS AND OBJECTIVES: To survey the patterns of concomitant use of Ayurveda and conventional anti-diabetic drugs by diabetic patients attending an out-patient department of a tertiary care teaching hospital in New Delhi, India through a validated questionnaire. MATERIALS AND METHODS: This is a questionnaire-based survey, carried out after the approval of the Institutional Ethics Committee, subsequently registered at CTRI. A questionnaire to assess the pattern of concomitant use was developed; content was validated and pre-tested by a pilot study in 40 patients, further refined and used in the survey. The data was analyzed to evaluate the patterns of concomitant use of Ayurvedic and conventional anti-diabetic drugs. RESULTS: About 95.9% of diabetic patients were taking herbo-mineral formulations concomitantly with conventional anti-diabetic drugs. Although 45.3% of diabetics were using Ayurveda interventions under the supervision of qualified AYUSH physicians, remaining involved in procuring the drugs over the counter (OTC) or from the local vendors. In majority of these instances, the use of Ayurveda formulations was not communicated with their physicians. CONCLUSION: The observations reveal that a majority of the diabetics (95.9%) were taking one or the other form of herbal preparations along with their conventional anti-diabetic drugs and about 44% among them were using these concomitantly. Thus, generating awareness on good practices of drug use seems to be essential.

Process standardization of Swarna Makshika Shodhana (purification) in Triphala Kwatha (decoction).

BACKGROUND: Swarna Makshika (SM) is a brassy golden yellowish mineral with chemical composition of CuFeS2 that is widely used in therapeutics to treat various disease conditions such as Prameha (diabetes), Pandu (anemia), Kushtha (skin diseases) and Jwara (fever). This mineral needs to be processed by the following specified Ayurveda guidelines in order to make it therapeutically safe and more potent. These processes include Shodhana (preliminary process of eliminating unwanted substances), Marana (incineration) and Amritikarana (nectorization) that are mandatory and play a crucial role in therapeutics. However, till date, no published reports are available on standard manufacturing procedure of SM Shodhana. OBJECTIVE: The objective of this study is to develop the standard manufacturing procedure of SM Shodhana. MATERIALS AND METHODS: Methods described in Rasaratna Samuchhaya were followed to perform Shodhana process. Shodhana of SM was carried out in three batches (600 g in each batch) by seven quenching in Triphala Kwatha (TK, decoction of Terminalia chebula Retz., Terminalia bellirica Roxb. and Phyllanthus emblica Linn.) maintaining batch manufacturing records. Organoleptic and physicochemical analysis of media, i.e., TK and SM was carried out. RESULTS: After Shodhana, golden yellowish luster of SM was completely lost and it turned into dark black coarse powder. The hardness went on decreasing and brittleness went on increasing. Average 532 g of Shodhita SM (88.67%) from 600 g of SM was obtained. Average time required for achieving red hot stage was 24.81 min. Analysis of the media revealed an increase in pH, specific gravity, and total solid contents. CONCLUSION: The adopted method for Shodhana of 600 g of SM can be considered as easy, convenient and standard.

Acute and subchronic toxicity study of Tamra Bhasma (incinerated copper) prepared with and without Amritikarana.

BACKGROUND: Tamra Bhasma (TB) is one among herbo-metallic preparations extensively used in routine ayurvedic practice. In the present era, Bhasma preparations used in ayurvedic system of medicines are always under stern observations for containing heavy metals which may raise the question of safety aspect. OBJECTIVE: In the present study, TB prepared with and without Amritikarana was subjected to toxicity study to ascertain the role of Amritikarana on safety profile of TB in rats. MATERIALS AND METHODS: Both the samples of TB were administered to rats for 28 consecutive days at the doses of 5.5, 27.5, and 55 mg/kg. The effects of both drugs were assessed on ponderal changes, hematological, serum biochemical, and histopathology of various organs. RESULTS: Results showed that both the samples of TB did not produce any sign and symptoms of toxicity at therapeutic dose level (5.5 mg/kg) and therapeutic equivalent dose (TED) × 5 (27.5 mg/kg) while at higher dose of TED × 10 (55 mg/kg) TB has mild toxicity in liver, kidney, heart, and thymus on repeated administration for 28 days in rats. The sample without Amritikarana has more magnitude of toxicity than the sample with Amritikarana. CONCLUSION: From the present study, it is concluded that TB with Amritikarana was found to be relatively safer than TB without Amritikarana at different dose levels in rats and hence suggest for safely use in humans at therapeutic dose level. It proves the role of Amritikarana in the preparation of TB.

Critical Review of Rasaratna Samuccaya: A Comprehensive Treatise of Indian Alchemy.

Rasaratna Samuccaya (RRS) a 13th century C.E. alchemical treatise, authored by Vagbhata, is a useful compilation related to preparation and properties of drugs of mineral and metallic origin. This text throws light on the state of Indian expertise in the field of alchemy regarding the extraction, purification, conversion of metals/minerals into therapeutically suitable forms, various instruments developed for alchemical purposes and treatment of numerous diseases by using herbo-mineral preparations. The present work is an attempt to summarize the key features of RRS to highlight its utility and contribution in the development of Indian alchemy. To study and summarize the important, comprehensive and specific points mentioned in RRS and to elaborate the contribution of RRS in the field of Indian alchemy. A critical review of RRS from Suratnojjvala Hindi commentary by Ambikadatta Shastri was done and the collected information was compared with other available literature of Rasasastra. Research of modern science was also utilized to explore some facts mentioned by Vagbhata. RRS is a precise treatise among available ancient literature. It comprises of all eight branches of Ayurveda, although it mainly deals with therapeutic aspects of Rasasastra and emphasizes the use of metals and minerals in treating nearly 68 types of ailments. It contains 30 chapters, 3871 verses and detailed description of 960 formulations. Classification of metals and minerals; description of some new instruments, formulations and averting use of metals and minerals in pregnancy are the key features of RRS.

Efficacy of Vasa Avaleha and its granules on Tamaka Shwasa (bronchial asthma): Open-label randomized clinical study.

INTRODUCTION: Bronchial asthma is one of the chronic inflammatory disorders of the respiratory tract causing a huge number of deaths annually. Increased industrialization and pollution are the exacerbating factors for this situation. In Ayurveda, this miserable condition is comparable with Tamaka Shwasa. Synthetic drugs provide instant symptomatic relief in cases of bronchial asthma but are known to develop certain adverse drug reactions. Considering this, the current suffering population is looking hopefully towards other systems of medicine such as Ayurveda for better relief. Ayurveda has a number of formulations to treat Tamaka Shwasa and is in practice with proven efficacy. AIMS: To evaluate comparative clinical efficacy of Vasa Avaleha (VA) and its granules (GVA) in cases of Tamaka Shwasa. MATERIALS AND METHODS: A total of 66 patients were registered and randomly grouped into A and B. Patients of Group A were treated with VA, while Group B with GVA at dose of 6 g twice a day with lukewarm water for the duration of 28 days. Follow-up was done after 14 days. The results were assessed in terms of clinical recovery, symptomatic relief, and pulmonary function improvement. Effect of the treatment was assessed based on subjective and objective parameters. RESULTS: Significant improvement was observed in most of the cardinal and associated symptoms. Significant increase in peak expiratory flow rate, considerable decrease in absolute eosinophil count, and increased breath holding time were noticed. Withdrawal of modern emergency drugs, decreased frequency of attacks, improved quality of life were the major observations noticed in both groups. CONCLUSIONS: This study highlights the significance of traditional herbal formulations in noncommunicable diseases such as bronchial asthma, which can be used as an effective drug in place or along with modern drugs.

Clinical efficacy of Apamarga Kshara Yoga in the management of Shvitra (vitiligo).

INTRODUCTION: Vitiligo is a progressive, idiopathic, pigmentation disorder of the skin, characterized by hypopigmented patches. This condition is compared with Shvitra in Ayurveda. Many Ayurvedic drugs are beneficial in such cases and Apamarga Kshara Yoga is one among them. AIM: To evaluate the efficacy of Apamarga Kshara Yoga in Lepa and ointment forms in the management of Shvitra. MATERIALS AND METHODS: Total 50 patients of Shvitra were randomly grouped into two. Patients registered in Group A (n = 25) were treated with Apamarga Kshara Yoga Lepa and Group B (n = 25) with Apamarga Kshara Yoga ointment for 2 months. Rasayana Churna (3g) along with Honey and Ghee was given twice daily internally in the both groups. RESULTS: Significant improvement was found in the symptoms of Shvitra with treatment in both the groups. The difference in between the groups was statistically insignificant. CONCLUSION: Both forms of Apamraga Kshara Yoga are effective in cases of Shvitra and can be good alternatives for contemporary medicines.

Pharmaceutical standardization of Kamsaharitaki granules.

INTRODUCTION: Kamsaharitaki Avaleha is a well-known ayurvedic preparation. Considering certain inconveniences of Avaleha, an attempt has been made to convert it into granules that are convenient in handling, dispensing, and storage. AIM: To convert Kamsaharitaki Avaleha into granules form and develop standard manufacturing procedure. MATERIALS AND METHODS: Seven pilot batches were prepared to fix the ratio of formulation composition. The procedure was repeated for 14 times to ensure the process validation. RESULTS: Converting into granules in presence of jaggery and Haritaki pulp is found to be difficult. Replacing these two with Khanda Sharkara and Haritaki powder yielded desired characteristics of granules. CONCLUSION: This modified proportion of ingredients can be considered as standard in preparing Kamsaharitaki Avaleha granules. As no manufacturing and physicochemical properties are available for Kamsaharitaki granules; the current findings can be considered as standard for future studies.

Fourier transform infrared analysis of Tamra Bhasma at different levels: A preliminary study.

INTRODUCTION: Tamra Bhasma, one among the herbo-metallic preparations is extensively used in Ayurveda for different conditions. To make it safe to use, Tamra has to pass through a set of classical pharmaceutical procedures including a series of quenching in prescribed liquids, followed by incineration with black sulfide of mercury and herbal juice of Citrus jambhiri Lush. and corm of Amorphophallus campanulatus Linn. FTIR profiles of Tamra Bhasma at different levels is not available. AIM: To evaluate the chemical changes in Tamra Bhasma at different steps by following Fourier transform infrared (FTIR) spectroscopy. MATERIALS AND METHODS: In current study, raw Tamra, intermediate samples obtained during purification, incineration and Amritikarana were analyzed using FTIR. RESULTS: It was observed that Shodhana procedure leads in the formation of bonds between surface particles of Tamra and Shodhana media. These formed bonds on the surface of Shodhita Tamra samples gave various sharp peaks representing presence of many functional groups. CONCLUSION: The FTIR spectra revealed that both Bhasma samples contained organic compounds probably in the form of a complex with common functional groups like alkyl, methyl, etc., which need further studies for exact characterization of the complexes.

Pharmaceutical standardization of Apamarga kshara.

Standardization of herbal drugs is essential to certify their quality and purity. Kshara (alkaline substance) of Apamarga (Achyranthes aspera Linn.) is an important constituent in many Ayurvedic formulations, but its standard manufacturing process (SMP) is not attempted till date. This study is aimed to establish SMP for Apamarga kshara. In pharmaceutical process; generally the sediments of ash obtained at the end of washes will be discarded. However, in the study, we attempted to wash the sediments repeatedly by adding water to extract more Kshara. Apamarga was collected from the local area and authenticated. Kshara was prepared by following standard methods and the preliminary physicochemical profile was developed. It is observed that the ash yields Kshara even in the consecutive washes. First wash yielded 21.23% w/w Kshara, while the second and third washes yielded 9.38% w/w and 4.76% w/w, respectively. Repeated washes yield more Kshara. Hence, it is advocated to wash the ashes repeatedly. As the findings are encouraging, similar experiments can be extended to all other Kshara preparations.

Comparative Anti-hyperlipidaemic activity of Navina (fresh) and Purana (old) Guggulu.

OBJECTIVE: Guggulu (Commiphora wightii [Arn.] Bhandari) is a well-known anti-hyperlipidaemic drug. Guggulsterones are active components of this drug which are responsible for this effect. The activity of Guggulu may depend upon its nature, fresh samples are recommended for their brhmana (body mass increasing) effect; while lekhana (scarificant) effect is attributed to the old one. The comparative Anti-hyperlipidaemic activity of fresh and old samples has not been reported till date. MATERIALS AND METHODS: Freshly collected and one year old samples of Guggulu were processed in gomutra. Patients who satisfied inclusion criteria of Hyperlipidaemia were randomly distributed into two groups and the drug was administrated in a dose of 1 g with luke warm water twice a day for eight weeks. RESULTS: Significant improvement was found in the symptoms of Medoroga and Lipid profile with treatment in both the groups. Fresh sample of Guggulu proved to have a better effect in lowering serum cholesterol (5.76%), triglyceride (17.17%), and very low density lipoprotein VLDL (18.36%) levels while old sample of Guggulu provided mild effect in lowering serum triglyceride (13.64%), VLDL (11.07%) and non-significant increase in serum HDL-cholesterol (0.94%). Old sample of Guggulu also provided significant decreases in body weight (7.69%) and BMI (7.82%). CONCLUSIONS: Old Guggulu showed better effect on body weight, BMI and cardinal symptoms along with significant lipid lowering effect whereas fresh Guggulu showed better result on lipid profile.

Shelf-life evaluation of Kamsaharitaki avaleha and its granules: A preliminary study.

BACKGROUND: Saviryata-avadhi (shelf life) of different Ayurvedic dosage forms is described in Sarngadharasamhita. Though the concepts have a strong background, we seek to re-evaluate the age old concepts by following current norms. An attempt has been made in the present study to evaluate shelf-life of Kamsaharitaki avaleha and its granules. MATERIALS AND METHODS: Raw materials were procured from Pharmacy, Gujarat Ayurved University, Jamnagar and utilized after proper authentication in pharmacognosy lab. The avaleha and its granules were prepared in the departmental laboratory following classical guidelines and subjected to accelerated stability studies. RESULTS: Both the products were found to be free from microbial contamination. Heavy metals were within the prescribed limit. Changes in physico-chemical profiles at different intervals are insignificant. On extrapolation of the observations, the shelf life of avaleha was found to be18 months and 27 months to the granules. CONCLUSION: Stability of granules was found to be comparatively higher than the avaleha. This observation may be exclusive to Kamsaharitaki avaleha. Studies on other avalehas and their granules need to be carried out to confirm this preliminary observation.

Assessment of genotoxic potential of hridayarnava rasa (a herbo-mineralo-metallic ayurvedic formulation) using chromosomal aberration and sperm abnormality assays.

OBJECTIVES: Herbo-mineral formulations are being successfully used in therapeutics since centuries. But recently, they came under the scanner for their metallic contents especially the presence of heavy metals. Hence it is the need of the hour to assess and establish the safety of these formulations through toxicity studies. In line with the various toxicity studies that are being carried out, Government of India expressed the need for conducting genotoxicity studies of different metal- or mineral-based drugs. Till date very few Ayurvedic herbo-mineral formulations have been studied for their genotoxic potential. The present study is aimed to evaluate the genotoxic potential of Hridayarnava Rasa. MATERIALS AND METHODS: It was prepared as per classical guidelines and administered to Swiss albino mice for 14 consecutive days. Chromosomal aberration and sperm abnormality assay were done to evaluate the genotoxic potential of the test drugs. Cyclophosphamide (CP) was taken as positive group and results were compared. RESULTS: All treated groups exhibited significant body weight gain in comparison to CP group. Results revealed no structural deformity in the above parameters in comparison to the CP-treated group. CONCLUSION: Reported data showed that both tested samples of Hridayarnava Rasa does not possess genotoxic potential under the experimental conditions and can be safely used.

Review of research works done on Tamra Bhasma [Incinerated Copper] at Institute for Post-Graduate Teaching and Research in Ayurveda, Jamnagar.

The metal, Tamra though mentioned in Ayurveda with a wide range of therapeutic utilities; is attributed with Ashta Maha Dosha. Hence, one should be cautious while using Tamra Bhasma. Considering the significance of Tamra in therapeutics, many studies have been carried out at different centers of India. Aim of the present study was to compile such available research works done on Tamra in the Department of Rasa Shastra and Bhaishajya Kalpana (RS and BK), IPGT and RA, Jamnagar and provide brief information about pharmaceutical, analytical, and pharmacological studies. Total eleven studies on Tamra Bhasma, which revalidated the impact of classical guidelines, safety issues, and therapeutic utilities, were screened from PG Department of RS and BK, Institute for Post-Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar. All studies revealed that Tamra Bhasma is safe clinically, experimentally at Therapeutic Equivalent Dose (TED) levels as no toxic hazards were reported during the treatment period. In all aspects (pharmaceutical, pharmacological, and clinical) Somnathi Tamra Bhasma has proven to be better than Tamra Bhasma. The clinical efficacy of Tamra Bhasma has been evaluated in Shvasa, Kasa, Yakrit Pliha Vriddhi, Grahani, etc. conditions. Satisfactory responses with a decrease in the intensity of signs and symptoms were reported in all the studies. Though certain limitations were observed in these researches, the results can be considered as a lead for further well stratified studies covering larger population. No adverse effects were reported in any of these studies.

Hypoglycemic and anti-hyperglycemic activity of Guduchi Satva in experimental animals.

Over the centuries, herbs have served as a major source of medicines for prevention and treatment of diseases including diabetes mellitus. These herbs are getting more importance around the globe and many studies have provided safety and efficacy of such herbal drugs in different condition. Guduchi (Tinospora cordifolia [Willd.] Miers) is reported as highly potent Pramehahara (anti-diabetic) herb in Ayurveda and Guduchi Satva (GS) is popularly used to treat Paittika type of Prameha. In the present study, GS prepared from the stem of T. cordifolia was evaluated for hypoglycemic and anti-hyperglycemic activity in 18 h fasted mice. GS was suspended in distilled water and administered to animals at the dose of 130 mg/kg that showed the marginal reduction in blood sugar level (BSL) at all the time intervals in normoglycemic mice. In anti-hyperglycemic activity, administration of GS prior to glucose over load failed to attenuate BSL at all-time interval in comparison to glucose control group. The study concludes that mild hypoglycemic insignificant anti-hyperglycemic activities of GS.