| CTRI Number |
CTRI/2025/12/098900 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study on Mulaka Paneeya Kshara And Palasha Paneeya Kshara In Cholithiasis |
|
Scientific Title of Study
|
Open Labelled, Randomized Comparative Clinical Study To Evaluate The Efficacy Of Mulaka Paneeya Kshara And Palasha Paneeya Kshara In The Management Of Pittashmari W.S.R Cholithiasis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tayyaba Kagadgar |
| Designation |
Associate Professor |
| Affiliation |
Ayurveda Mahavidylaya Hospital |
| Address |
Left Wing, Department of Prasuti Tantra & Stree Roga, Ayurveda Mahavidyalaya & Hospital, Heggeri Colony
Hubli
Dharwad
KARNATAKA
580024
India |
| Phone |
8073527269 |
| Fax |
|
| Email |
tayyabakagadgar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tayyaba Kagadgar |
| Designation |
Associate Professor |
| Affiliation |
Ayurveda Mahavidylaya Hospital |
| Address |
Left Wing, Department of Prasuti Tantra & Stree Roga, Ayurveda Mahavidyalaya & Hospital, Heggeri Colony
Hubli
Heggeri Extesion
Hubli
KARNATAKA
580024
India |
| Phone |
8073527269 |
| Fax |
|
| Email |
tayyabakagadgar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tayyaba Kagadgar |
| Designation |
Associate Professor |
| Affiliation |
Ayurveda Mahavidylaya Hospital |
| Address |
54 Heggeri Colony
Hubli
Heggeri Extesion
Hubli
KARNATAKA
580024
India |
| Phone |
8073527269 |
| Fax |
|
| Email |
tayyabakagadgar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tayyaba Kagadgar |
| Address |
54 Heggeri Colony Old Hubli |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Tayyaba Kagadgar |
Ayurveda Mahavidyalaya Hospital |
OPD No 21, Department of Shalya Tantra, Right Wing, Heggeri Extension, Hubli
Dharwad
KARNATAKA |
8073527269
tayyabakagadgar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurveda Mahavidyalaya Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K806||Calculus of gallbladder and bile duct with cholecystitis. Ayurveda Condition: PITTAJA-ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Palasha Kshara, Reference: Chakradatta, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Moolaka Kshara, Reference: chakradatta, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with features of Cholithiasis |
|
| ExclusionCriteria |
| Details |
Patients with gallstones associated with complications such as obstructive cholecystitis acute cholangitis acute pancreatitis liver failure congestion of gall bladder calcified gall bladder carcinoma of gall bladder cirrhosis hepatomegaly jaundice
Immune compromised patients
Uncontrolled diabetes mellitus hypertension
Pregnant woman and lactating mother
gall bladder polyp and duct polyp |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the Size of Gall Bladder stone |
Reduction in the Size of Gall Bladder stone |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain |
45 days |
| Reduction in Nausea |
45 days |
| Reduction in Vomitting |
45days |
| Number of Calculus |
45 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparing Palasha Kshara and Moolaka Kshara in the management of Cholithiasis with special reference to Pittaja Ashmari |