An open comparative clinical evaluation on “Sagana Vadham” (cervical spondylosis) with siddha trial drugs “Pancha Pashana Chendhuram” (internal), “Kurunthotti Thailam” (external) and “Varmam Therapy”

Rajanandhini, M (2017) An open comparative clinical evaluation on “Sagana Vadham” (cervical spondylosis) with siddha trial drugs “Pancha Pashana Chendhuram” (internal), “Kurunthotti Thailam” (external) and “Varmam Therapy”. Masters thesis, Government Siddha Medical College, Chennai.

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Abstract

An open clinical trial with the Siddha trial drug PanchaPashanaChendhuram (Int), Kurunthotti oil (Ext) and Varmam therapy in Saganavatham (Cervical spondylosis) has been chosen for the dissertation work by the author. Various literatures dealing with Saganavatham have been collected from various Siddha and Modern text books and also Drugs review is also said. Standard operating procedure for both internal and external drugs was standardized. Standardization of drug (PPC) through both traditional and modern way of technique physico chemical analysis had been done. Pre-clinical toxicity study was done for the trial drug PPC using wistar albino rats. Toxicity study in animals was carried out after obtaining proper permission from Institutional Animal Ethical Committee (IAEC). Anti – inflammatory activity for the trial drug PPC was done. Analgesic activity for the trial drug PPC was done by Eddy’s Hot plate method in rats. The study is conducted after the drug being screened by the Screening committee and the trial is also approved by the Institutional Ethical Committee (IEC). A clinical trial was conducted to evaluate the efficacy of trial drugs PPC (Int), Kurunthotti oil (Ext) &Varmam therapy in Saganavatham patients, 60 patients of both sex and in age group between18 to 60 were selected for the study. In OPD 20 patients were treated with Internal, External drugs and Varmam therapy, 20 patients were treated with Internal and External drugs, 20 patients were treated with External oil and Varmam therapy. All the details about the study and the drugs were informed to the patients in their vernacular language and consent forms duly signed by them were obtained from them. Separate proforma was maintained for each and every patient. Before starting the treatment, the blood samples of the selected patients were subjected to investigation and X-ray were taken. From the first day onwards PanchaPashanachendhuram, 65 mg twice daily was Giveninternally, Kurunthotti oil for externaluse and Varmam were given to thepatients. After the study period the patients were subjected to investigation, clinical assessment and X-ray. The clinical assessment was assessed by using pain assessment scale. The safety of the trial drug PPC was assessed by comparing the safety parameters (LFT and RFT) before and after treatment. Finally statistical analysis was performed to assess the significance of the trial. CONCLUSION: Organoleptic characters exposed standardization of Chendhuram. PPC has been screened for toxic effects. For sub- acute toxicity studies 2 doses of 5X dose is 10mg/animal,10X dose is 20mg/animal were administered orally for 28 days. Animals were observed for physiological and behavioral changes, food and water intake, body weight changes and mortality. All the animals were sacrificed and changes in organ weights and histology were examined no mortality was observed and on treatment related changes occur. Hence the PPC had no toxic effect the drug to be safe. PPC have significant effect of anti-inflammatory and analgesic activity. Efficacy of the drugs PPC, Kurunthotti thailam and Varmam was evaluated in Saganavatham patients. The result of the study was concluded by reducing PAIN Assesement scale. There is certainly marked changes noted in the grading of the result. 75% 0f the cases out of 60 didn’t have a Pain. The overall result of the study was, 75% of the patients had good progress, 15% of them had moderate improvement and 10% had mild progress. It was safe and well-tolerated as none of the patients showed significant change in LFT and RFT before and after the trial. During the course of treatment there were no adverse effects or unwanted drug reactions in GIT, RS, CVS and Excretory systems such as nausea, mouth ulcers, abdominal discomfort, dyspnoea, cough, palpitation, raised blood pressure, dysuria/oliguria, pedal edema and colour changes in the palm. Even though SOP of PPC have variation from textual SOP, it has ended in finished product that satisfied the traditional standardization techniques, modern standardization techniques and it proves the safety and efficacy in treating the diseases in both pre-clinical and clinical aspect. The drug is effective in short duration of treatment in very little amount of dose are other advantages. All groups of economic peoples using this medicine have good response.

Item Type: Thesis (Masters)
Additional Information: (Reg.No. 321413104)
Uncontrolled Keywords: saganavadham ; cervical spondylosis ; siddha trial drug ; Pancha Pashana Chendhuram ; Kurunthotti Thailam ; Varmam Therapy ; open comparative clinical study.
Subjects: AYUSH > Sirappu Maruthuvam
Depositing User: Kambaraman B
Date Deposited: 24 Sep 2018 02:00
Last Modified: 24 Sep 2018 02:00
URI: http://repository-tnmgrmu.ac.in/id/eprint/9602

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