Phase I and II Non Randomized Open Clinical Trial on the Effectiveness of “Erukku Elai Ottradam” in Thandagavadham of both Gender Aging between 30-60 Years attending in OPD at AAGHIM (Branch VII - Pura Maruthuvam)

Durga, L (2020) Phase I and II Non Randomized Open Clinical Trial on the Effectiveness of “Erukku Elai Ottradam” in Thandagavadham of both Gender Aging between 30-60 Years attending in OPD at AAGHIM (Branch VII - Pura Maruthuvam). Masters thesis, Government Siddha Medical College, Chennai.

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Abstract

I have to summarize this study with the following highlights. The 60 cases of Thandagavadham were diagnosed clinically. Among 60 patients, 30 patients were treated with Erukku Elai Ottradam in OPD, 30 patients were treated with Erukku Elai Ottradam in IPD for 30 days in Department of Pura Maruthuvam, Government Siddha Medical College, Chennai-106. The study Protocol was approved by Institutional Ethical Committee (GSMC-CHME-5/013/2018). Before initiating the clinical trial, it was registered in Clinical Trial Registry of India and the registration number Ref No Is: CTRI/2019/06/019865. The various siddha methods of examination of the disease were carried out and the data were recorded in the prescribed proforma for the 60 selected cases. During the period of treatment all the patients are advised for Pathiyam (specific dietary regimen chart for the disease given to each patient). Laboratory investigations are done periodically for all the cases before and after treatment and radiological investigations are done for all the cases before treatment. The observations made during the clinical study showed that external medicine is effective in relieving the pain in Thandagavatham patients. During the study period, there was no adverse event reported. As per the Siddha Literature and recent research articles, the ingredients of the trial drugs was found to have anti- inflammatory and analgesic properties owning to the disease manifestations. The mean pain score before treatment was 7.75, after treatment it was reduced to 0.85. Hence, this study reveals that patients treated with trial medicine and massage procedure showed good enhancement when compared to those who were treated only with trial medicine. Statistical analysis showed significant reduction in the pain score and questionnaire before and after treatment. The outcome of the trial medicine was assessed by grading method and the results were as follows: Good improvement – patients (75%), Moderate improvement – patients (22%) Mild improvement – patients (3%). CONCLUSION: Low back pain is a universal human experience almost everyone has it as some point. Among the galaxy of causative factors both spinal and extra spinal, the common cause of low back ache seems to be the lumbar disc disease. At this level progressive biochemical and structural changes take place leading to a modification in the physical properties of elasticity and mechanical resistance. ➢ Thandagavatham is mainly due to derangements of Vadha humour. ➢ The ERUKKU ELAI OTTRADAM is a plants based application of siddhaexternal treatment procedure. There is no harmful and adverse reactions noted in phase-I study and hence proved to be safe for human administration. ➢ Physiochemical properties of the raw drugs, Erukku and Veppennai has collected and mentioned for the significant anti-inflammatory and analgesic activity. The drugs has authenticated by authorised siddha research institute. ➢ The clinical trial proves the effectiveness of trail drug by reducing the clinical signs and symptoms like radiating pain, numbness, restricted movements and provides better improvement. The study results show that 8% of them had mild improvement, 18% of them had moderate improvement and 74% of them had good improvement after treatment. Thus these results revealed good relief from the disease after treatment. ➢ The preparation of trial medicine is economical. The trial medicines were prepared from easily available ingredients. Patients treated with trial medicine and massageprocedure showed good enhancement when compared to those who were treated only with trial medicine. ➢ The clinical trial conducted in selected patients was satisfactory encouraging. Further studies may be taken up to establish the efficacy of the drug. ➢ Therefore the author concluded that the trial medicine ERUKKU ELAI OTTRADAM can give better solutions for Thandagavatham (Lumbar Spondylosis).

Item Type: Thesis (Masters)
Additional Information: 321717101
Uncontrolled Keywords: Phase I and II, Non Randomized Open Clinical Trial, Effectiveness, Erukku Elai Ottradam, Thandagavadham, 30-60 Years.
Subjects: AYUSH > Maruthuvam
Depositing User: Subramani R
Date Deposited: 23 Nov 2021 17:15
Last Modified: 23 Nov 2021 17:15
URI: http://repository-tnmgrmu.ac.in/id/eprint/18634

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