1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [justdoit.partha007@gmail.com].
   


6. For how long will this data be available start date provided 01-12-2029 and end date provided 31-12-2034?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Cholelithiasis is a common chronic disease of the hepatobiliary system in India which may be symptomatic or asymptomatic. The prevalence of cholelithiasis varies and has been reported as 2-29% in India, and increased in the recent years. The majority of gallstones are asymptomatic and merely 10% of these may develop symptoms. Hence, most gallstones are clinically “silent,” and an accidental finding often uncovered during abdominal ultrasound being performed for another reason. Symptomatic gallstones manifest either as biliary pain/colic or cholecystitis. They may experience intense pain in the upper-right side of the abdomen, often accompanied by nausea and vomiting, that steadily increases for approximately 30 min to several hours. Along with these non-specific symptoms They include the isolated heartburn, acid regurgitation, belching, nausea, vomiting, bloating, abdominal distention, chest pain, postprandial fullness or early satiety and flatulence may also be present. On examination patients may have jaundice and right quadrant tenderness may be present with palpitation, a positive Murphy sign may be elicited. Often, attacks occur after a particularly fatty meal and almost always happen at night. Ultrasonography has a specificity and sensitivity of 90-95%, and can detect stones as small as 2 mm in diameter.

Although Cholecystectomy is the gold-standard for Cholelithiasis, routine Cholecystectomy for all subjects with silent gallstones or mild symptoms is always not necessary. Cholelithiasis cases do frequently come to homoeopathic clinics. Time and again, Homoeopathy has proved effective in treatment of gall bladder stones. Inspite of published evidence-based cases reports, clinical trials related to gallstones is lacking and hence needs to be designed.

This prospective, open-labelled clinical trial is designed to assess the efficacy of homoeopathic medicines in cholelithiasis cases. For evaluation ultrasonography will be done at base line, 6^th and 12^th month along with LFT and Lipid profile. Quality of life will be assessed via  Gastrointestinal Quality of Life Index (GIQLI) at baseline, 6^th month and 12^th month. Indicated homoeopathic medicine as per symptom similarity would be selected on the basis of totality of symptoms, followed by repertorization. Selected medicine would be prescribed in 6C potency at the start of the treatment. Dosage schedule will be as per requirement of the case. During the period of the study, the potency would be raised sequentially as per the need of the case, in pursuance with the homoeopathic principles.