| CTRI Number |
CTRI/2024/07/069872 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy of Ksharamladi yoga and Yava Paneeya kshara in patients with Cholelithiasis |
|
Scientific Title of Study
|
Comparative clinical study on the efficacy Of Ksharamladi Yoga and Yava Paneeya Kshara in the management of Pittashaya ashmari(cholelithiasis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veekshitha |
| Designation |
Pg scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan |
| Address |
Department of Shalya tantra
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital,BM Road Thanniruhalla,Hassan
KARNATAKA
573201
India
Hassan
KARNATAKA
573201
India |
| Phone |
8971346572 |
| Fax |
|
| Email |
drveekshithapadukone@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr prasanna narasimha rao |
| Designation |
Principal and professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan |
| Address |
Department of Shalya Tantra
OPD No. 12
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, BM Road Thanniruhalla, Hassan
KARNATAKA
573201
India
Hassan
KARNATAKA
573201
India |
| Phone |
9448064277 |
| Fax |
|
| Email |
profpnrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr prasanna narasimha rao |
| Designation |
Principal and professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan |
| Address |
Department of Shalya Tantra
OPD No. 12
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, BM Road Thanniruhalla, Hassan
KARNATAKA
573201
India
Hassan
KARNATAKA
573201
India |
| Phone |
9448064277 |
| Fax |
|
| Email |
profpnrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of shalya tantra,OPD No.11 and 12,Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 India |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr veekshitha |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
Department of Shalya Tantra
OPD No. 12 and 11
BM road, Thanniruhalla
Hassan 573201
Karnataka
India
Hassan
KARNATAKA |
8971346572
drveekshithapadukone@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri dharmasthala manjunatheshwara college of ayurveda and hospital hassan 573201 karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K802||Calculus of gallbladder without cholecystitis. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ksharamladi yoga, Reference: rasa tarangini kshara trika adhyaya, Route: Oral, Dosage Form: Kshara , Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: yava paneeya kshara, Reference: sushruta samhita, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with any of the clinical features of cholelithiasis like localized pain in epigastrium,right hypochondrium,occasionally radiate to the right scapular tip,nausea,flatulent dyspepsia.
2.Asymptomatic cholelithiasis detected incidently in USG.
3.Subjects having gall stones aged between 20-60 years will be selected.
4.Subjects with stone size measuring upto 8mm |
|
| ExclusionCriteria |
| Details |
1.Subjects with cholelithiasis associated with complications like jaundice,cholecystitis,Acute and Chronic pancreatitis,Mirizzi syndrome,Empyema of gall bladder,Carcinoma of gall bladder.
2.Pregnant and lactating women.
3.Systemic disorders and conditions like uncontrolled Diabetes,Cardiovascular disorders,Liver failure,immune compromised conditions which interferes with the course of treatment and requiring surgical interventions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the size of gall stones based on
1.USG Abdomen and pelvis
|
Baseline,60 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Significant clinical relief in signs & symptoms of cholelithiasis like Localized pain in epigastrium, right hypochondrium, occasionally radiate to the right scapular tip, nausea, flatulent dyspepsia.
|
will be assessed baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
31/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/07/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
An open label double arm randomized comparative clinical prospective study on the efficacy of ksharamladi yoga on pittashaya ashmari,cholelithiasis in a age group of 20-60 years for a period of 60days. During this study period, 40 patients will be recruited and divided into two groups, Group A (trial drug) patients will be administered ksharamladi yoga (10ml bd with water) and Group B (Control drug) patients will be administered yava paneeya kshara (500mg bd) for a period of 60days. clinical assessment will be done for both subjective and objective criteria on 1st,31st,67th day .Statistical analysis will be done through data obtained on 0 day(BT) AND 67th day(AT) . |