Efficacy and safety of "Jollab Monzej" as a traditional persian compound medicine for the treatment of multiple sclerosis-related fatigue: A randomized placebo-controlled trial.

Background: The purpose of this study was to investigate the efficacy and safety of Jollab monzej (JMZ), a Traditional Persian compound medicine, on multiple sclerosis-related fatigue (MSRF). Methods: We did a double-blind randomized controlled phase3 clinical trial on the JMZ syrup in fifty-six relapsing-remitting MS (RRMS) patients aged 18-55 years with moderate to severe fatigue using the Expanded Disability Status Scale (EDSS) score ≤ 6. We randomly assigned (1;1) participants to the JMZ syrup or placebo syrup groups treated for one month. Participants, investigators, and assessors were unaware of the assignments. The primary outcome was changes in the fatigue score on the Fatigue Severity Scale (FSS), at baseline and one month after treatment using the intention-to-treat (ITT) analysis. The secondary outcomes were changes in the score of Visual Analogue Scale (VAS), Beck Depression Inventory (BDI), and Pittsburgh Sleep Quality Index (PSQI). Outcomes were measured at baseline, one month after treatment, and 2-week follow-up. Safety was detected in all participants. Results: We randomly assigned 56 participants to the JMZ group (n=28) and placebo group (n=28). Fatigue scores significantly changed in both groups; however, the JMZ group had a greater reduction in FSS score in the ITT analysis. The adjusted mean difference was 8.80 (Confidence interval (CI) 95%, 2.90-14.70, P = 0.00). The mean difference of VAS, BDI, and global PSQI scores were statistically significant (P=0.01, P₌0.00, P₌0.01; respectively). Regarding safety, mild adverse events (AEs) were reported. Conclusion: The results of our study revealed that the administration of JMZ syrup alleviated MSRF and also could improve depression and sleep disorders.

Beneficial effects of Teucrium polium hydroalcoholic extract on letrozole-induced polycystic ovary syndrome in rat model.

OBJECTIVE: Polycystic ovary syndrome (PCOS) is an endocrine disorder that disrupts the menstrual cycle and causes infertility. Considering the increasing use of medicinal plants, the present study aimed to evaluate the effects of Teucrium polium L. on letrozole-induced PCOS in female rats. METHODS: Six groups of rats (n=7 each) were evaluated. The control group received 1% carboxy methyl cellulose as vehicle, while the five other groups received letrozole 1 mg/kg orally for 21 days. After PCOS induction, the rats were orally administered T. polium extract (50, 100, and 200 mg/kg) or metformin (200 mg/kg) for 28 days. Subsequently, body and ovarian weights and serum levels of follicle stimulating hormone, luteinizing hormone (LH), estradiol, progesterone, and testosterone were measured. Finally, the ovarian tissues were isolated for histological examination. RESULTS: There were no significant changes in weekly body weight in any group. After 21 days of letrozole administration, PCOS induction was confirmed by estrous cycle irregularities and increased LH and testosterone levels. After treatment with the hydroalcoholic extract of T. polium, testosterone and LH levels were significantly reduced in all groups (P<0.05). Histological studies of ovaries in the metformin and T. polium groups exhibited normal follicular development with fewer and smaller cystic follicles than those in the PCOS group. CONCLUSION: The hydroalcoholic extract of T. polium improves serum levels of sex hormones, restores ovarian morphology in PCOS-induced rats, and is a good candidate for further clinical trials.

Effects of Herbal Medicines on the Prevention and Treatment of Contact Dermatitis: A Systematic Review.

Background: Contact dermatitis (CD) is a common inflammatory disease of the skin. CD has a complex and multifaceted treatment, and one of the main components of CD treatment is inflammation management. We summarized the clinical trials exploring the effects of herbal medicine on patients with CD. Methods: A systematic review was performed by searching four databases. Clinical trials in English investigating the effect of herbal medicines on CD prevention and treatment published from 2010 to 2020 were reviewed. This study was conducted based on the PRISMA guidelines. Results: Nine clinical trials examining the effects of herbs on CD were identified. A total of 450 patients participated in these studies. Herbal medicines used in the reviewed studies were in various forms. Almost all the studies showed that these herbs were useful in preventing and treating CD. Regarding the side effects of the herbal medicines, few complications such as erythema and papules as well as positive chronotropic effects were reported. Conclusion: Evidence showed that herbal medicines were effective in preventing and treating CD by reducing the inflammation level and increasing antioxidant defense. However, the number of clinical trials was low to draw definitive conclusions. Moreover, the studies were not homogeneous and differed regarding methodology, evaluation tools, and quality. Also, in these studies, the interactions and safety of the herbal medicines were not considered adequately. Therefore, well-designed evidence is required to draw definitive conclusions in this regard.

Efficacy and Safety of Jollab (a Saffron-Based Beverage) on Cancer-Related Fatigue in Breast Cancer Patients: A Double-Blind Randomized Clinical Trial.

INTRODUCTION: Fatigue is a common complaint in cancer patients and profoundly affects the quality of life of the patients. Therefore, we designed a clinical trial to evaluate the safety and efficacy of Jollab (containing saffron, honey, and rose water) as a tonic beverage in the management of cancer-related fatigue in breast cancer patients. METHODS: Seventy-five patients were randomly assigned into two groups, patients received either 4 weeks Jollab or the placebo (20 mL three times daily). Fatigue was assessed with scores of Visual Analogue Fatigue Scale (VAFS), Fatigue Severity Scale (FSS), and Cancer Fatigue Scale (CFS) at weeks 0 and 4 (before and after the intervention). RESULTS: In the Jollab group, VAFS showed a significant decrease (p = 0.000), but in the placebo group, there was no significant difference (p = 0.258). In the Jollab group, FSS decreased significantly (p = 0.000), while in the placebo group, it slightly decreased (p = 0.096). CFS physical and cognitive subscales also showed improvement of fatigue in the Jollab group compared to the placebo group (p < 0.05), but affective subscale score did not show a significant change after the intervention in both groups (p > 0.05). CONCLUSIONS: Jollab beverage has significant positive effects on reducing fatigue in women with breast cancer. However, larger-scale trials with further sample size and longer period of the intervention are needed to confirm and develop our preliminary findings.

Herbs as old potential treatments for lymphedema management: A systematic review.

INTRODUCTION: Herbs have been reported to be effective in reducing lymphedema burden. This paper aimed to review literature reporting on herbs for lymphedema treatment. METHODS: A systematic review was performed using the PRISMA guideline. Clinical studies on herbal intervention and lymphedema were included. Evidence on the effectiveness of herbal interventions for desired outcomes including reduction of edema volume, other symptoms, quality of life and inflammation were collected and assessed in detail. RESULTS: In all twenty studies were included in this review. Of these 14 studies were randomized clinical trials and the rest were prospective pilot studies. Herbal treatment was reported for breast cancer-related lymphedema in most studies and coumarin was the most reported herb that used for lymphedema management. Edema volume reduction (17 out of 20) and symptoms improvement (15 out of 20) were the outcomes reported in most studies. CONCLUSION: Phytochemicals can be a promising pharmacotherapy for lymphedema management. However, further evidence is needed to establish definite effectiveness for the use of herbal remedies for lymphedema management.

Anti-Freckles Herbal Treatment in Iranian Traditional Medicine.

BACKGROUND: Freckles are numerous pigmented spots of the skin, mainly confined to the face, even arms and back. Although freckles are light-brown macules, most frequently observed in individuals with red or blond hair, they are common to Asian people too. Freckles increase in number, size, and depth of pigmentation during the summer months. Histologically, freckles show increased production of melanin pigment by a normal number of melanocytes. Freckles commonly stop spreading before adolescence and last for life, but could sometimes be subtle in adulthood. Treatments are often requested for cosmetic purposes. Before the advent of lasers, treatment modalities for pigmentary disorders included surgical excision, dermabrasion, chemical bleaching, and peeling. These treatments may lead to unwanted side effects of potential scarring or undesired pigmentation changes. In Iranian traditional medicine (ITM), freckles have been known as well. "Namash" was the term used by ITM scholars to indicate freckles. There is a wide range of plants, which were prescribed by Iranian physicians for the treatment of freckles. The purpose of this study is to find the most frequent useful herbs for freckles as mentioned in ITM references. METHODS: Seven ITM references were studied for anti-freckles medicines. The references were Canon of Medicine (Avicenna), Alhavi (Razes) Tuhfat ul-Momineen (Momen tonekaboni), Makhzan-ul-Adwiah (Aghili), Ikhtiyarat Badi'i (Ansari), Al-abnia An-Haghyegh el-advia (Heravi), and al-jami li-mufradat al-adwiyawa al-aghdhiya (Ibn al-Baitar). Moreover, plants were ordered according to their repetition in the references. Afterwards, traditional names of the selected plants were matched with the scientific names using botanical text references. RESULTS: This study demonstrated that Myristica fragrans Houtt, Cicer arietema L., Eruca sativa Lam., Lilium candidium L., Amygdalus communis L., Arum italicum L. were the most frequent herbs mentioned in ITM references for the treatment of freckles. CONCLUSION: Herbs mentioned in this article could be appropriate candidates for future studies in the field of freckles treatment.

The Most Frequent Herbs Proposed by Iranian Traditional Medicine for Alopecia Areata.

BACKGROUND: Alopecia areata (AA) is a common immune-mediated hair loss disorder. AA has a reported incidence of 0.1-0.2% with a lifetime risk of 1.7%. Histologically, AA is characterized by the accumulation of mononuclear cells around the bulb of the affected hair follicles. Corticosteroids are the most popular drugs for the treatment of this disease. Despite its high prevalence, currently available treatments are mostly unsatisfactory and inefficient for the more chronic and severe types of the AA. Alopecia areata is a well-known disorder in Iranian traditional medicine (ITM). "Da oth-tha,lab" was the term used by ITM scholars to indicate AA. Traditional Iranian physicians believed that the presence of morbid matter in the scalps is the main cause of the disease, which blocks nutrients and causes hair roots to deteriorate. Herbal medicines in the form of topical preparations were applied by ITM scholars for the treatment of AA. This study was performed to determine the most frequent useful herbs for AA as mentioned in ITM. METHODS: Seven ITM references such as Canon of Medicine (Avicenna), Alhavi (Razes) Tuhfat ul-Momineen (Mo,men tonekaboni), Makhzan-ul-Adwiah (Aghili), Ikhtiyarat Badi,i (Ansari), Al-abnia An-Haghyegh el-advia (Heravi) and al-jami li-mufradat al-adwiyawa al-aghdhiya (Ibn al-Baitar) were studied for anti-AA medicines. Subsequent to our study, the herbal medicines were listed and scored based on the frequency of their prescriptibility. Moreover, we took the effort to provide the best scientific name for each plant. RESULTS: This study showed that Allium cepa L., Artemisia abrotonon L., Allium sativum L., and Asphodelus ramosus L. were the most frequent herbs mentioned in ITM references for the recovery of AA. CONCLUSION: These herbs can be introduced as new herbal medicines for clinical research in the field of alopecia areata treatment.

Formulation of a Traditionally Used Polyherbal Product for Burn Healing and HPTLC Fingerprinting of Its Phenolic Contents.

Nowadays, plants have been considered as powerful agents for treatment of disorders regarding to their traditional use. In Iranian Traditional Medicine (ITM), plants have a special role in the treatment of various diseases. Burns with their devastating outcomes have been discussed in ITM as well. In the present study, a polyherbal ointment (PHO), retrieved from ITM, was formulated for burn healing and it's HPTLC fingerprint was prepared. Aqueous extracts of Malva sylvestris and Solanum nigrum leaves and oily extract of Rosa damascena petals (4.85%, 4.85% and 33%, respectively) were added to white beeswax, eucerin and white petrolatum as ointment base. In addition to the microbiological tests, physical stability and rheological behavior of the product were assessed. Fingerprinting of phytochemical constituents of PHO was performed by using silica gel plates and toluene: ethyl acetate: acetic acid (60:40:1) and ethyl acetate: formic acid: acetic acid: water (100:11:11:10) as mobile phases. The results showed that PHO was stable towards physical changes and successfully passed microbiological tests. Moreover, PHO exhibited plastic behavior which is in favor of a topical burn product. In addition, HPTLC fingerprinting of PHO demonstrated the presence of several phenolic constituents corresponding to the plant extracts. Regarding to the role of phenolic compounds in wound healing process, PHO could be an appropriate candidate for burn healing with respect to its traditional use in ITM. Moreover, HPTLC fingerprinting could be utilized as an applicable method for quality control of the prepared formulation.

Wound Healing Activity of a Traditionally Used Poly Herbal Product in a Burn Wound Model in Rats.

BACKGROUND: Burns are known as one of the most common and destructive forms of injury with a vast spectrum of consequences. Despite the discovery of various antibacterial and antiseptic agents, burn wound healing still has remained a challenge to modern medicine. Plants, with a valuable traditional support, have been considered as potential agents for prevention and treatment of disorders in recent years. However, modern scientific methods should be applied to validate the claims about the therapeutic effects of the herbal products. OBJECTIVES: This study was conducted to evaluate the wound-healing activity of a poly herbal cream (PHC), retrieved from Iranian Traditional Medicine (ITM), in a rat burn wound model in Iran. MATERIALS AND METHODS: In this experimental study, PHC containing aqueous extracts of Malva sylvestris and Solanum nigrum leaves and oily extract of Rosa damascena petals was used. Second-degree burn wounds were induced in four groups of five rats each. Group 1 received no treatment while groups 2, 3 and 4 were given cream base, silver sulfadiazine (SS) 1% and PHC, respectively to compare the efficacy of PHC with the negative and positive control groups. The percentage of wound healing on days 2, 6, 10 and 14 and histopathological parameters of healed wounds on the 14th day were assessed. Antioxidant and antimicrobial activities of PHC were evaluated using 2, 2-diphenyl-1-picrylhydrazyl (DPPH) and micro-dilution methods, respectively. RESULTS: There was a significant improvement in healing percentage of PHC-treated rats in comparison to the other groups at the end of the treatment period (87.0% ± 2.1% for PHC in comparison to 32.2% ± 1.6%, 57.0% ± 5.3% and 70.8% ± 3.5% for the control, cream base and SS groups, respectively). Moreover, the healed wounds in PHC-treated animals contained less inflammatory cells and had desirable re-epithelialization with remarkable neovascularization. In addition to the antioxidant activity, PHC exhibited antibacterial effect against Staphylococcus aureus. CONCLUSIONS: Poly herbal cream experimentally and histopathologically revealed a burn wound healing activity probably due to the antioxidant, anti-inflammatory and antimicrobial activities of its phytochemical contents. Therefore, this study confirms the use of M. sylvestris, S. nigrum and R. damascena in burn prescriptions in ITM.