A Comparative Study To Evaluate The Combined Efficacy Of Vamana, Virechana And Rohitakadi Choornam Versus Rohitakadi Choornam Alone In The Management Of Pittashya Ashmari (Cholelithiasis): An Open-Label Randomized Controlled Clinical Trial

This dissertation synopsis proposes a randomized controlled clinical trial aimed at comparing the efficacy of combined Ayurvedic Panchakarma therapies—Vamana, Virechana, and Rohitakadi Choornam—versus Rohitakadi Choornam alone in the management of Pittashya Ashmari (Cholelithiasis or gallstones). The research, submitted by Dr. Sakshi, a postgraduate scholar at the All India Institute of Ayurveda, New Delhi, has undergone multiple revisions in response to feedback from both the Institutional Review Board and the Institutional Ethics Committee.

The rationale for the study lies in the pressing clinical need for non-surgical interventions in gallstone treatment. Modern medicine primarily recommends cholecystectomy as the standard procedure; however, this surgical approach often leads to postoperative complications such as post-cholecystectomy syndrome, digestive disturbances, and impaired bile storage, all of which can negatively affect quality of life. In contrast, Ayurveda offers a holistic, dosha-balancing therapeutic approach through Panchakarma procedures and herbal formulations that may minimize these risks. This clinical trial not only seeks to validate such Ayurvedic interventions but also aims to provide evidence for their integration into mainstream healthcare systems.

The primary objective of the trial is to compare the reduction in gallstone size, as measured through ultrasonography, between the two treatment groups. Secondary objectives include evaluating improvements in clinical symptoms, liver function tests, and lipid profiles. The trial is designed as an open-label randomized controlled study with a total sample size of 30 participants, randomized into two equal groups of 15 each. Group A will be administered

sequential Ayurvedic interventions including Deepana-Pachana, Snehapana, Abhyanga, Swedana, followed by Vamana and Virechana, culminating with Rohitakadi Choornam. Group B will receive a placebo for the first 30 days, followed by Rohitakadi Choornam. The duration of the trial for each participant will be 90 days, with hospitalization arranged for Panchakarma procedures whenever necessary.

Inclusion criteria for participants are defined as adults aged 20 to 60 years with ultrasonography-confirmed gallstones measuring less than 3 cm, along with classical symptoms of cholelithiasis, and no prior biliary surgery or acute complications. Exclusion criteria include the presence of conditions such as jaundice, cholecystitis, cholangitis, carcinoma of the gallbladder, pancreatitis, liver failure, uncontrolled diabetes, pregnancy, or any indication necessitating surgical intervention.

Outcome assessments will include both subjective and objective measures. Subjective outcomes will be evaluated using validated scales for pain, nausea, vomiting, and other symptomatic aspects. Objective assessments will involve serial ultrasonography examinations, liver function tests, and lipid profile analysis. Statistical analysis will be performed using appropriate tests such as paired and independent t-tests, ANOVA, Mann-Whitney U, Wilcoxon’s test, and McNemar’s test depending on the data type and distribution.

The study has been designed in strict adherence to ethical guidelines laid down by AYUSH, ICMR, and WHO. Informed consent from all participants will be mandatory, and confidentiality will be maintained through the anonymization of data during analysis and reporting. Any adverse drug reactions will be carefully monitored, documented, and reported as per pharmacovigilance procedures. Oversight of the trial’s progress and compliance measures will be maintained by an independent review committee.

The anticipated impact of this study is significant, as it represents one of the first clinical trials to systematically compare major Panchakarma therapies with a standardized herbal formulation in the management of gallstones. It addresses critical gaps in Ayurvedic research, such as the limited number of comparative clinical studies, the absence of standardized clinical protocols, and the lack of large-scale evidence. Through this trial, Ayurveda may establish itself as a safe, effective, and holistic alternative for gallstone management, thereby fostering greater acceptance within contemporary medical practice.

The estimated budget for the study amounts to sixty-eight thousand rupees, covering costs for investigations, medications, and ancillary requirements. Ethical clearance and mandatory registration in the Clinical Trial Registry of India will be secured prior to the commencement of the trial. Overall, this rigorous clinical protocol has the potential to contribute substantially to the scientific validation of Ayurveda and its integration into modern healthcare, promising improved outcomes for patients with cholelithiasis.