Efficacy & safety evaluation of Ayurvedic treatment (Ashwagandha powder & Sidh Makardhwaj) in rheumatoid arthritis patients: a pilot prospective study.

Background & objectives: In the traditional system of medicine in India Ashwagandha powder and Sidh Makardhwaj have been used for the treatment of rheumatoid arthritis. However, safety and efficacy of this treatment have not been evaluated. Therefore, the present study was carried out to evaluate the efficacy and safety of Ayurvedic treatment (Ashwagandha powder and Sidh Makardhwaj) in patients with rheumatoid arthritis. Methods: One hundred and twenty five patients with joint pain were screened at an Ayurvedic hospital in New Delhi, India. Eighty six patients satisfied inclusion criteria and were included in the study. Detailed medical history and physical examination were recorded. Patients took 5g of Ashwagandha powder twice a day for three weeks with lukewarm water or milk. Sidh Makardhwaj (100 mg) with honey was administered daily for the next four weeks. The follow up of patients was carried out every two weeks. The primary efficacy end point was based on American College of Rheumatology (ACR) 20 response. Secondary end points were ACR50, ACR70 responses, change from baseline in disease activity score (DAS) 28 score and ACR parameters. Safety assessments were hepatic function [alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin and β2 microglobulin], renal function (urea and creatinine and NGAL) tests and urine mercury level. Results: The study was completed by 90.7 per cent (78/86) patients. Patients with moderate and high disease activity were 57.7 per cent (45/78) and 42.3 per cent (33/78), respectively. All patients were tested positive for rheumatoid factor and increased ESR level. Ashwagandha and Sidh Makardhwaj treatment decreased RA factor. A significant change in post-treatment scores of tender joint counts, swollen joint counts, physician global assessment score, patient global assessment score, pain assessment score, patient self assessed disability index score and ESR level were observed as compared to baseline scores. ACR20 response was observed in 56.4 per cent (44/78) patients (American College of Rheumatology criteria) and moderate response in 39.74 per cent (31/78) patients [European League Against Rheumatism (EULAR) criteria]. Ayurvedic treatment for seven weeks in rheumatoid arthritis patients showed normal kidney and liver function tests. However, increased urinary mercury levels were observed after treatment. Interpretation & conclusions: The findings of the present study suggest that this Ayurvedic treatment (Ashwagandha powder and Sidh Makardhwaj) has a potential to be used for the treatment of rheumatoid arthritis. However, due to small sample size, short duration, non randomization and lack of a control group as study limitations, further studies need to be done to confirm these findings.

Rhinosporidiosis: a clinicopathological study from a Rural Tertiary Health Care Centre, Bihar, India.

Rhinosporidiosis is a chronic granulomatous infection characterized by a bleeding polypoidal mass which commonly affects the nose and nasopharynx. The disease is caused by Rhinosporidium seeberi. It grows in stagnant water and is thought to be transmitted to human by infected soil and water by gaining entry through traumatized epithelium and mucosa of nose and nasopharynx. It has a high incidence of occurrence among rural population. Surgical excision is the treatment of choice. Methods: Totally, 26 patients of histologically proven cases of rhinosporidiosis were included in this clinicopathological study. The mode of presentation in all these patients was polypoidal nasal mass causing recurrent bleeding and nasal obstruction. The period of study was from May 2010 to April 2014. All patients treated surgically were followed-up from 6 months to 1 year. Results: There were 26 patients of histologically proven rhinosporidiosis of nose and nasopharynx. Of total 26 cases, there were 19 males and 9 female patients in our study with a male to female ratio of 2.7:1. The age of presentation varied from 14 years to 67 years, most patients presenting in the second to sixth decade of life with maximum patients in the third and fourth decade of life and were from rural and poor socio-economic background. Recurrent cases were given dapsone. Conclusion: Rhinosporidiosis which was previously thought to be a fungus is now considered as a protoctista parasite, which involves fish and other amphibians, a fungus like protozoa of the class mesomycetozoea.

Safety evaluation of mercury based Ayurvedic formulation (Sidh Makardhwaj) on brain cerebrum, liver & kidney in rats.

Background & objectives: Sidh Makardhwaj (SM) is a mercury based Ayurvedic formulation used in rheumatoid arthritis and neurological disorders. However, toxicity concerns due to mercury content are often raised. Therefore, the present study was carried out to evaluate the effect of SM on brain cerebrum, liver and kidney in rats. Methods: Graded doses of SM (10, 50, 100 mg/kg), mercuric chloride (1 mg/kg) and normal saline were administered orally to male Wistar rats for 28 days. Behavioural parameters were assessed on days 1, 7, 14 and 28 using Morris water maze, passive avoidance, elevated plus maze and rota rod. Liver and kidney function tests were done on day 28. Animals were sacrificed and brain cerebrum acetylcholinesterase activity, levels of malondialdehyde (MDA), reduced glutathione (GSH) in brain cerebrum, liver, kidney were estimated. The levels of mercury in brain cerebrum, liver and kidney were estimated and histopathology of these tissues was also performed. Results: SM in the doses used did not cause significant change in neurobehavioural parameters, brain cerebrum AChE activity, liver (ALT, AST, ALP bilirubin) and kidney (serum urea and creatinine) function tests as compared to control. The levels of mercury in brain cerebrum, liver, and kidney were found to be raised in dose dependent manner. However, the levels of MDA and GSH in these tissues did not show significant changes at doses of 10 and 50 mg/kg. Also, there was no histopathological change in cytoarchitecture of brain cerebrum, liver, and kidney tissues at doses of 10 and 50 mg/kg. Interpretation & conclusions: The findings of the present study suggest that Sidh Makardhwaj upto five times the equivalent human dose administered for 28 days did not show any toxicological effects on rat brain cerebrum, liver and kidney.

The hypolipidemic activity of Ayurvedic medicine, Arogyavardhini vati in Triton WR-1339-induced hyperlipidemic rats: A comparison with fenofi brate.

Background: Hyperlipidemia is a major risk factor of coronary heart disease. Currently available hypolipidemic drugs have been associated with number of side effects. Arogyavardhini vati, an Ayurvedic polyherbal formulation has been used for liver disorders. Therefore, present study was designed to evaluate the effect of Arogyavardhini vati in Triton WR-1339-induced hyperlipidemia in rats. Objectives: Anti-hyperlipidemic activity evaluation of Arogyavardhini vati against Triton WR-1339-induced hyperlipidemia in rats. Materials and Methods: Overnight fasted male Wistar rats (150-200 g) were randomly divided into normal control group [4% Dimethyl Sulfoxide (DMSO), i.p.], positive control group (Triton WR-1339 in 4% DMSO, 400 mg/kg, i.p.), standard drug treated (fenofi brate 65 mg/kg, p.o. for 7 days after inducing hyperlipidemia) and Arogyavardhini vati treated (50, 100, 200 mg/kg, p.o. for 7 days after inducing hyperlipidemia). Rat doses were calculated by extrapolating the equivalent human dose (therapeutic dose, sub-maximum, and maximum dose). Serum total cholesterol, triglyceride, low-density lipoprotein (LDL), high-density lipoprotein HDL, liver malondialdehyde (MDA), and glutathione (GSH) levels were estimated at end of experiments. Results: Arogyavardhini vati signifi cantly decreased serum cholesterol, triglyceride, LDL, and C-reactive protein (CRP) and signifi cantly increased serum HDL in a dose-dependent manner. Decreased MDA and increased GSH levels in liver were observed at all doses of Arogyavardhini vati (50, 100, 200 mg/kg) and fenofi brate-treated groups when compared with Triton-treated group. Atherogenic Index (AI) level was signifi cantly decreased in fenofi brate and Arogyavardhini vati (200 mg/kg) treated rats when compared with normal control. Conclusion: Arogyavardhini vati, a traditionally used Ayurvedic medicine may be a useful therapy for hypercholesterolemia through reducing oxidative stress (decreasing MDA and increasing GSH) and lipid levels.

Evaluation of antitussive activity of formulations with herbal extracts in Sulphur Dioxide (SO2) induced cough model in mice.

Cough is the most common symptom of respiratory diseases. When cough becomes serious, opioids are effective, but they have side effects like sedation, constipation, some addiction liability and also compromise the respiratory function. Therefore, there is need to have effective anti-tussive agent which do not have respiratory suppressant activity. The present study was carried out to evaluate anti-tussive activity of combination of herbal drugs as formulations in sulphur dioxide (SO2)-induced cough model in mice. Albino mice of either sex, weighing 25-30 g were divided into eight groups, (n = 6). Group 1 served as normal control, group 2 mice were given distilled water, group 3 was positive control and received codeine sulphate (10 mg/kg, p.o.) and group 4, 5, 6, 7 received coded l formulations 1, 2, 3 and 4 respectively at a dose of 0.3 ml/mice, orally, while group VIII was the vehicle control. Thirty minutes later, the mice were exposed to sulphur dioxide again for 45 sec. The mice were then placed in an observation chamber for counting of cough bouts, by two independent observers, for five minutes. All the formulations used showed significant antitussive activity in sulphur dioxide induced cough model. Thus, these formulations can prove to be useful for alleviating cough.