Suganthi, M (2018) An Open clinical study on Merugulli Thylam (Internal) in the treatment of Vali Azhal Keelvayu (Rheumatoid Arthritis). Masters thesis, National Institute of Siddha, Chennai.
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Abstract
The aim of the study was to evaluate the efficacy of the drug MERUGULLI THYLAM (Internal) in Vali azhal keelvayu. Before initiating the clinical trial, approval was got from the Institutional Ethical Committee for conducting the clinical study by submitting the well defined protocol and proforma. IEC NO: NIS/IEC/2016/11-07/14.10.2016 • Then the clinical trial was registered in CTRI(Clinical Trial Registry -India). After that the enrolment of patients was started. CTRI NO: CTRI/2018/03/012365. • The raw drugs were authenticated by the Assistant Professor, Medicinal Botany and the trial drug was prepared by the investigator in the Gunapadam lab of National Institute of Siddha as per the Standard Operating Procedure mentioned in the protocol. • Bio chemical studies were done at the bio chemistry lab of National Institute of Siddha, The standardization and TLC & HPTLC were done at the Captain Srinivasa Murthy Regional Ayurveda Drug Development Institute, Arumbakkam, Chennai. (as per letter of CSMRADDI) And detection of aflatoxin were done in Regional Research Institute of Unani Medicine, Royapuram respectively. • Among the 105 cases screened at the OPD of department of Maruthuvam NIS, 40 cases were recruited for the trial as per the inclusion and exclusion criteria. • Clinical diagnosis of valiazhal keelvayu was made by Siddha and Modern methodology. • Before inducement into the trial informed consent was obtained from the patients. Out of the 40 cases 39 cases were treated in OPD and 1 case in IPD. • The trial medicine selected for Internal treatment was MERUGULLI THYLAM 9 ml/dose morning only in empty stomach with the adjuvant hot water referred under Siddha literature Theraiyar Thylavarga Surukkam. • During the treatment period of 45 days the trial drug MERUGULLI THYLAM (internal) is given for 3 days followed by a re dieting (drug holiday) of 2 days. Likewise the medicine is given till the end of the course. • Diet restriction was strictly followed during the period of drug administration as well as re dieting period (Diet free of salt, coconut, horse gram etc) as per noted in the form IV (Dietary advice form). • Required lab investigations were carried out before and after the treatment and the data was recorded in the proforma. • Clinical assessment was done daily in IP patient and OP patients it was assessed once in 5 days. • During the study period, there was no event of any adverse reactions owing to the drug or disease. • In these studies out of 40 cases 81.4% of cases showed reduction in pain. There was improvement in other clinical symptoms before and after treatment revealing the effect of drug in reducing the pain and other clinical symptoms. Thus improvement of the patients in their daily life activities. • As per the Siddha Literature and modern science reviews and research articles, the ingredients of the trial drugs were found to have the property of controlling the Vatha diseases, some drugs exhibited anti inflammatory, anti analgesic activities owing to the disease manifestations. • Clinical Lab parameters there was reduction in RA factor, CRP and ASO titre [RA factor- 27 cases (67.5%) positive at commencement of the treatment 9 (33.3%) were screened negative after the treatment, CRP-25 cases (62.5%) positive at commencement of the treatment 6(24%) were screened negative after the treatment, ASO titre -10 cases positive at commencement of the treatment 2(20%) cases were screened negative after the treatment] and ESR - 49.7% reduction in ESR ½ HR and 52.44% reduction in ESR 1 HR which showed the therapeutic effect of the drug in controlling the disease to a greater extent. • Statistical analysis showed significant reduction in pain scale and a significant reduction in ESR value after treatment indicating the control over the inflammatory process of the disease. • Bio chemical analysis showed the precence if inevitable constituents like Iron,Calcium,Sulphur which played a role in repairing and preventing the joint damage in the disease. • TLC & HPTLC – HPTLC finger print of Merugulli thylam could serve as a marker and which is responsible for expression of its biological and clinical actions. • HPTLC was carried out in UV at 254 nm , UV at 366 nm to establish the finger printing profile and to show the possibly active phyto chemical constituents. • In 254 nm UV the peak corresponds to the Rf values 56.51% has maximum peak area of 4140.6 AU(area 43.84%) is a marker. • In 366 nm UV the peak corresponds to the Rf values 83.03% % has maximum peak area of 2547.0 AU(area 80%) is a marker • No Aflatoxins were detected in Merugulli thylam. CONCLUSION: Statistical analysis [Paired “t” test] revealed that the therapeutic efficacy of the trial drug Merugulli thylam by showing, reduction in pain 81.4% of cases. (Universal pain assessment scale: Ref: Clinical Manual for Nursing Practise National Institute of Health Warren Grant Magnuson Clinical Centre) • As per cross tabulation (vide table no.32) 30 cases (75%) came under Grade I (Fit for all activities) & 10 cases (25%) came under Grade II (Mild restriction) after the treatment. It revealed that 100% cases showed Good improvement in functional ability. • There is a significant reduction in the elevated lab parameters [RA factor- 27 cases (67.5%) positive at commencement of the treatment 9 (33.3%) were screened negative after the treatment, CRP-25 cases (62.5%) positive at commencement of the treatment 6(24%) were screened negative after the treatment, ASO titre -10 cases positive at commencement of the treatment 2(20%) cases were screened negative after the treatment]. • The mean ± standard deviation before treatment is 32.02± 19.75 and after treatment is 16.1 ±10.91 for ESR ½ hr. The analysis revealed that there is 49.7% reduction in ESR ½ hr compared to start of the treatment. • The mean ± standard deviation before treatment is 57.97± 32.54 and after treatment is 27.57 ±19.52 for ESR 1 hr. The analysis revels that there is 52.44% reduction in ESR 1 hr compared to start of the treatment. • There were no adverse reactions complained during the trial period. • The results of the clinical trial indicates that the trail drug MERUGULLI THYLAM is clinically effective,safe and also economical. • Because of the encourage clinical outcome, the study may be further carried out with the same durg in large number of cases.
| Item Type: | Thesis (Masters) |
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| Additional Information: | (Reg.No: 321511207) |
| Uncontrolled Keywords: | Merugulli Thylam ; Vali Azhal Keelvayu ; Rheumatoid Arthritis ; Open clinical study. |
| Subjects: | AYUSH > Maruthuvam |
| Depositing User: | Subramani R |
| Date Deposited: | 29 Dec 2018 13:48 |
| Last Modified: | 29 Dec 2018 13:48 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/10228 |
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