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• W2891404556 abstract "AIM AND OBJECTIVES:AIM:The aim of the study is to evaluate the safety and therapeutic efficacy of the Siddha formulation “Vediyuppu Kattu” (Internal Medicine) in the treatment of “Vaayu Kunmam” (Gastritis).OBJECTIVES:1. PRIMARY OBJECTIVE:To evaluate the therapeutic efficacy of the Siddha formulation “Vediyuppu Kattu” (Internal Medicine) in the treatment of “Vaayu Kunmam” (Gastritis).2. SECONDARY OBJECTIVE:• To evaluate the safety profile of the trial drug (Acute and Long term toxicity studies) to be carried out as per W.H.O guidelines 1993.• To conduct a clinical trial with a well defined proforma on the patients identified with“Vaayu Kunmam”• To screen the biochemical constituents of the trial drug “Vediyuppu Kattu”.• To study the influence of other co factors such as age, sex, dietary habits, family history,socio economic status, habitat etc on the disease.• To find out the side effects / adverse effects of the drug “Vediyuppu Kattu” if any.SUMMARY:The aim of the study was to evaluate the safty and efficacy of the drug Vediyuppu Kattu in the treatment of Vaayu Gunmam.• Before initiating the clinical trial, approval was got from the Institutional Animal Ethical Committee IAEC : 1248/ac/09/CPCSEA/4-06/2011 – 6 Dt. 20.12.2011and Institutional Ethical Committee IEC : NIS/IEC/2011/3/06 – Dt. 24.12.2011 for conducting the pre clinical studies and clinical studies respectively by submitting the well defined protocol and proforma.• The raw drugs were authenticated by the concerned department and the trial drug was prepared in the Gunapadam lab of National Institute of Siddha as per the Standard Operating Procedure mentioned in the protocol.• The medicine was then subjected to toxicity studies (Acute and long term toxicity studies) as per the protocol and the safety of the drug was ensured.• The qualitative and quantitative bio chemical studies were done at the bio chemistry lab of National Institute of Siddha.• SEM analysis and trace metals detection were done at Sophisticated Analytical Instrument Facility, IIT, Chennai.• Among the 70 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 Vaayu Gunmam was made by Siddha and Modern methodology.• Before inducement into the trial informed consent was obtained from the patients.Out of the 40 cases 28 cases were treated in OPD and 12 cases in IPD.• A day before the trial drug administration, puragation was given to correct the elevated Vatha thathu and bring other two deranged thathus to equilibrium.The clinical trial was conducted with the trial medicine Vediyuppu Kattu 800 mg b.i.d with Thiri Kadugu Chooranam 400 mg internal, for a period of 48 days, referred under the Siddha literature Yaakoobu Vaidhiya Chinthamani 700 respectively.• Diet restriction was strictly followed during the period of drug administration. as per noted in the form IV E (Dietary advice form).• Required lab investigations were carried out before and after the treatment and the concerned data was recorded in the proforma.• Clinical assessment was done daily in all the IP patients and in OP patients it was assessed once in 7 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, 35 cases (87.5%) were found to be relieved from the clinical symptoms. In 3 cases (7.5%) the clinical symptoms were found to be reduced and no reduction was found in 2 cases (5%).• 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 disease Vaayu Gunmam.• Endoscopic evaluation of the patients before and after treatment shows thereduction of inflammation in the stomach. This showed the therapeutic effect of the drug in controlling the disease to a greater extent.• Statistical analysis showed significant reduction in symptoms and health assessment score assessed before and after the treatment (P< 0.010). Statistical analysis on lab parameters and toxicity studies also showed significant outcome.• Oral toxicity studies conducted ensured the safety usage of the drug to animals up to a maximum dose of 28.8 mg/animal for mice and 288mg/animal for wister rat.• Bio chemical analysis showed the presence of inevitable constituents like Calcium, Iron, Sulphate which plays a role in repairing and preventing the Gastric mucosal damage and inflammation in the disease.• The minimum particle size (0.5 - 2μ) unveiled in the (Particle Per Million size) PPM analysis shows the existence of the drug in micro particle size which contributes its therapeutic effect by the increased bio availability.CONCLUSION:The safety studies (the acute toxicity and long term toxicity) conducted revealed that the trial drug was safe even at higher dosage of 28.8 mg/animal for mice and 288mg/animal for wister rat. There were no abnormalities found in blood investigation and histopathological examination. Hence it can be reasonably assumed that the drug is safe for human.• Clinical study revealed the therapeutic efficacy of the trial drug by showing, complete relief in 87.5% (35) cases and reduction of symptoms in 3 (7.5%) cases out of 40 cases.• Improvement was noted in the Endoscopic evaluation of patients after the treatment when compared with before, revealing the control of the disease.• There were no adverse reactions observed during the trial.• Because of the encouraging clinical outcome, the study may be further carried out with the same drug in a large number of cases of Vaayu kunmam." @default.
• W2891404556 created "2018-09-27" @default.
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• W2891404556 date "2013-04-01" @default.
• W2891404556 modified "2023-09-27" @default.
• W2891404556 title "Preclinical and Clinical study on Vaayu Kunmam" @default.
• W2891404556 hasPublicationYear "2013" @default.
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