Phase II Non-Randomized Clinical study on “Bala Karappan (Atopic Dermatitis)” with Evaluation of Siddha Trial Drug “Sengathari Pattai Kudineer” (Internal) and “Murungai Pushpam Ennai” (External)

Sowmiya, D (2021) Phase II Non-Randomized Clinical study on “Bala Karappan (Atopic Dermatitis)” with Evaluation of Siddha Trial Drug “Sengathari Pattai Kudineer” (Internal) and “Murungai Pushpam Ennai” (External). Masters thesis, Government Siddha Medical College, Chennai.

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The clinical study was conducted with the trial drug SENGATHARIPATTAI KUDINEER as internal and MURUNGAIPUSHPAM ENNAI as external medicine for the disease BALAKARAPPAN through Pre-clinical and Clinical study methods. The trial drug was selected from the Siddha Literature “Sengathari pattai kudineer” from Theraiyar Kudineer-100 and “Murungai pushpam ennai” from Aathma Ratchamirdham Ennum Vaidhiya Saranga Sangiragam. The study was conducted after being screened by the screening committee and approved by the INSTITUTIONAL ETHICS COMMITTEE(IEC) of Govt Siddha Medical College, Chennai. The results of Pre-clinical and Clinical studies of trial drug stated whether to reject or accept the null hypothesis. The standards of Preclinical studies carried as per PLIM guidelines, the values of the results of physiochemical, phytochemical, biochemical analysis shows below the limits of AYUSH guidelines. There is no abnormality detected in aflatoxin, pesticide residue and microbial study. Heavy metal analysis revealed the absence of heavy metal present in the trial drug. Animal study reported the safety of the trial drug in both acute and sub-acute toxicity studies. Histopathology reports result that no pathological report present in the result. The Pre-clinical studies proven the safety of the drug Sengathari pattai kudineer (Internal) and Murungai pushpam ennai (external). The Clinical Study followed the methodologies for selection of study participants and the study got approval by IEC and IAEC clearance. The clinical study was registered in CTRI as per the regulation. The efficacy of the trial drug is proven by reducing the severity score in EASI scale during follow-up and the results was statistically proven significance of (p<0.000). The significance of the disease was reduced after 28 days treatment. Sengathari pattai kudineer (Internal) and Murungai pushpam ennai (external) was proven that it is clinically effective for Balakarappan. Regarding Siddha diagnostic methods, the essential diagnostic tools had been used for the diagnosis of Balakarappan. The adverse effect of the drug was not reported by the study participants during the full study. Totally 46 children with Karappan diagnosed clinically treated with outpatient department of Arignar Anna Hospital of Indian Medicine Chennai -106. 6 patients were withdrawing from the study. The outcome measures proven the safety and efficacy of the trial drug in Balakarappan and the null hypothesis was rejected with significance value of (p<0.000) CONCLUSION BALA KARAPPAN is a common skin condition in children and mainly caused by derangement of Kaba kuttram followed by vatham and pitham .In this clinical study ‘SENGATHARIPATTAI KUDINEER’ as internal and ‘MURUNGAI PUSHPAM ENNAI’ as external respectively .The deranged kuttram is settled down by the Kaippu suvai the trial drug sengatharipattai kudineer (milagu-kaippu suvai, chinni illai- kaippu suvai, sengatharipattai – kaippu suvai) present in the trial medicine settled down the disease thereby the medicine acts as Ethirurai Maruthuvam to cure the skin condition. No adverse effects were noticed on or after the treatment period. The clinical trial conducted in selected patients was satisfactory and inspiring. The trial medicine is safe and effective for Bala karappan in children. Through this study, the effectiveness of trial drug is confirmed and re-established by the author. LIMITATION OF THE STUDY: The clinical study conducted with minimum study participants. The study followed a non-randomized study method; it will not minimize the error of the study. The pharmacological study was limited due to the short period of time. RECOMMENDATION: This study conducted with minimum study participants to prove the efficacy. In the future study may elaborate with a greater number of study participants. Randomized technique is to minimize the errors in the clinical study, the RCT technique, The blinding methodology will reduce the error of the future studies.

Item Type: Thesis (Masters)
Additional Information: 321814104
Uncontrolled Keywords: Bala Karappan, Atopic Dermatitis, Evaluation, Siddha Trial Drug, “Sengathari Pattai Kudineer, Murungai Pushpam Ennai, Phase II Non-Randomized Clinical study.
Subjects: AYUSH > Kuzhanthai Maruthuvam
Depositing User: Subramani R
Date Deposited: 17 Nov 2022 15:46
Last Modified: 17 Nov 2022 15:46

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