Ramamurthy, M (2016) Scientific validation of the safety and efficacy of Siddha Herbo-mineral formulation Arumuga Chendhuram at it‟s intendant human therapeutic dosage in the management of Paithiya Vatha Suronitham – Advanced stage of Rheumatoid Arthritis. Doctoral thesis, The Tamilnadu Dr. M.G.R. Medical University, Chennai.
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Abstract
Rheumatoid arthritis (RA) is a chronic; non suppurative, autoimmune disorder predominantly affects female. It is a multisystem disease causing inflammation on the synovium of joints especially wrists and metacarpophalangeal and proximal interphalangealjoints of hand. Along with this, larger joints like elbows, ankles and knees are also involved symmetrically. The manifestations of advanced stage of RA can be correlated with the Vatha type of disease “PaithiyaVathaSuronitham” in Siddha system of Medicine. For treating this vatha disease, numerous medications were illustrated in the Siddha literatures. Among them, an herbometallicSastric formulation “Arumuga Chendhuram (ARC)” has been practiced a long time for treating arthritis. ARC has been chosen for the study to prove it is a safer and efficacious drug in the management of advanced stage of RA in both animal and human model. ARC has been prepared by many Siddha Pharma industries. For the study, we optimized the best variety of ARC among the self-prepared ARC and ARC procured from GMP certified Pharmacy. ARC procured from the industry was coded as Sample I and ARC prepared as per the method cited in the 1940 drug and cosmetic act authenticated literature “Siddha VaithiyaThirattu” was coded as Sample II. The both samples were analysed for qualitative and quantitative estimation. Preliminary physical parameters such as total ash, moisture content and extractive values were analysed. The functional groups were analysed by FT-Raman Spectroscopic study. The crystalline nature of ARC II and main contents were analysed using X ray diffraction study. The content of lead and cadmium were analysed using Atomic Absorption Spectroscopic study. The concentration of elements in oxide form wasanalysed through Wavelength dispersive X-Ray Fluorescence. The concentration of trace and heavy metals were analysed using Inductively Coupled Plasma – Optical Emission Spectrometer. From the result of above studies, we inferred that sample II was feasible to conduct the study on animal and human model. ARC II has lower concentrations of Mercury, Arsenic and Iron on compared with ARC I. Mercuric sulphide, sodium borate and ferric oxide were found as major constituents in ARC. To evaluate the safety of ARC, Wistar albino rats were used for performing acute and sub acute studies following OECD guidelines. 2g/kg of ARC was tested on six rats and observed nil mortality and morbidity. Median lethal dose was estimated as more than 2g/kg for the test drug. The sub-acute toxicity was observed on Wistar rats by giving ARC at three dose levels (12, 24 & 48 mg/kg) for 28 days along with its vehicle (Diluted honey). The test drug dose was fixed from the human conversion dose (260 mg/day) to rat. No mortality and abnormal clinical signs were observed during 28 days. All test dose treated animals gave comparable body weight and organ weight gain with that of control. Haematological, biochemical parameters and urinalysis were within the normal limit. No significant abnormality was detected in gross necropsy study on organs and in H&E sliced organs. The efficacy of ARC at the dose of 24 and 48 mg/kg was evaluated on BALB/C mice and Wistar rats. Acetic acid induced writhing test was performed on mice and observed ARC has significant analgesic activity by inhibiting the incidence of writhing as compared to control. Cotton pellet granuloma method was performed on rat and observed ARC has significant anti-inflammatory activity by reducing the granuloma formation. Anti-arthritic activity of ARC was performed on rat by inducing arthritis by two methods viz., Injecting Complete Freund‟s adjuvant and Collagen with Complete Freund‟s adjuvant. ARC has exhibited significant inhibition of paw oedema on injecting above materials and significant increase in body weight during 42 days treatment. The safety and efficacy of ARC at its therapeutic dose 130 mg/dose suspended with vehicle honey for two times daily for the duration of 60 days was done on human. The study was designed as non- randomized open labelled without control single centric study. The age group between 20 to 49 years and both sex of 55 patients were recruited after analysing the inclusion and exclusion criteria. The patients were recruited having ARC/EULAR score more than six. Only 44 patients (7 male and 37 female) were completed the study of 60 days treatment and completed the study. The intensity of pain was observed using universal pain assessment scale and modified health assessment questionnaire (MHAQ) scoring was done for functional assessment on before and after treatment. RA factor and CRP levels were reduced to low positive and negative in all patients treated. The intensity of severe pain was reduced from 65% to 5% after treatment. The life style function was increased in the patients assessed by the reduction of mean MHAQ score from 1.475 to 0.75 on 44 patients after treatment. No adverse event was observed during entire study.
| Item Type: | Thesis (Doctoral) |
|---|---|
| Uncontrolled Keywords: | Scientific validation, safety and efficacy, Siddha Herbo-mineral formulation, Arumuga Chendhuram, intendant human therapeutic dosage, Paithiya Vatha Suronitham, Advanced stage of Rheumatoid Arthritis. |
| Subjects: | AYUSH > Noi-naadal |
| Depositing User: | Subramani R |
| Date Deposited: | 14 Jan 2020 17:35 |
| Last Modified: | 15 Oct 2022 14:58 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/11837 |
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