| CTRI Number |
CTRI/2025/10/095571 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Rohitakabhaya kwatha in management of Non alcoholic fatty liver disease. |
|
Scientific Title of Study
|
“CLINICAL EVALUATION OF ROHITAKABHAYA KWATHA IN NON-ALCOHOLIC FATTY LIVER DISEASE” |
| 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 Charu Sharma |
| Designation |
Professor |
| Affiliation |
Quadra Institute of Ayurveda and Hospital Roorkee Haridwar |
| Address |
Opd No 3 Department of Kayachikitsa Quadra Institute of Ayurveda and Hospital NH 58 Roorkee Haridwar Road Near Montfort School Roorkee Haridwar 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
7060398172 |
| Fax |
|
| Email |
charu22jan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Sharma |
| Designation |
Professor |
| Affiliation |
Quadra Institute of Ayurveda and Hospital Roorkee Haridwar |
| Address |
Opd No 3 Department of Kayachikitsa Quadra Institute of Ayurveda and Hospital NH 58 Roorkee Haridwar Road Near Montfort School Roorkee Haridwar 247667
UTTARANCHAL
247667
India |
| Phone |
7060398172 |
| Fax |
|
| Email |
charu22jan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nancy |
| Designation |
PG Scholar |
| Affiliation |
Quadra Institute of Ayurveda and Hospital Roorkee Haridwar |
| Address |
Opd No 3 Department of Kayachikitsa Quadra Institute of Ayurveda and Hospital NH 58 Roorkee Haridwar Road Near Montfort School Roorkee Haridwar 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9313303417 |
| Fax |
|
| Email |
nancypanjeta07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nancy Opd No 3 Department of Kayachikitsa Quadra Institute of Ayurveda and Hospital NH 58 Roorkee Haridwar Road Near Montfort School Roorkee Haridwar(India) 247667 |
|
|
Primary Sponsor
|
| Name |
Nancy |
| Address |
Opd No 3 Department of Kayachikitsa Quadra Institute of Ayurveda and Hospital NH 58 Roorkee Haridwar Road Near Montfort School Roorkee Haridwar(India) 247667 |
| 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 |
| Nancy |
Quadra Institute of Ayurveda and Hospital |
Opd No 3 Department of Kayachikitsa Quadra Institute of Ayurveda and Hospital NH 58 Roorkee Haridwar Road Near Montfort School Roorkee Haridwar 247667
Hardwar
UTTARANCHAL |
9313303417
nancypanjeta07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Quadra Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRU, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rohitakabhaya kwatha, Reference: Chakradatta 38/4, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having ultrasonographical evidence of NAFLD and BMI (25-40 Kg/m2).
2. Patient’s having altered serum liver enzymes levels defined as serum ALT and AST more than normal (>40 IU/L) but less than two times of the upper limit of the normal value(<80 IU/L).
3. Subjects of either sex, age group 20-60 years who are non-alcoholics or they have history of alcohol intake less than 20 g/day.
|
|
| ExclusionCriteria |
| Details |
1. Patients who is unwilling to participate in study.
2. Patients having serum liver enzymes AST and ALT more than 2 times of upper normal limit.(i.e.AST more than 76 U/L; ALT more than 82 U/L)
3. Patients having ultrasonographical evidence of cirrhosis or necrosis of liver.
4. Patient who is consuming alcohol.
5. Patient testing positive for hepatitis B & hepatitis C, uncontrolled diabetes, malignancy of liver or having any other comorbidity.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in subjective parameters:
1.Utklesha
2. Chardi
3. Aruchi
4. Hridkantadaha
5. Udarashoola |
First assessment 15 days post- treatment initiation.
Second Assessment- 15 days after the first assessment.
Third Assessment- 15 days after the second assessment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in objective parameters:
1. Anthropometric measurements - Body weight, BMI
2. Biochemical tests - FBS, ALT, AST, GGT, AST/ALT Ratio, Alkaline phosphatase
3. Lipid profile - Serum cholesterol, Triglycerides, LDL, HDL, VLDL
4. Radiological - USG Whole Abdomen
|
Assessment will be done on day 0 and 45 day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
13/10/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is an open label clinical study to evaluate Rohitakabhaya kwatha in Non Alcoholic fatty liver disease. It will be a clinical study of 30 patients suffering from Non alcoholic fatty liver disease. Patient will be selected randomly irrespective of their gender, race, religion, occupation. Patients with classical features of Yakritdalyodara attending the OPD/IPD of Kayachikitsa Department of Quadra Institute of Ayurveda and Hospital, Roorkee will be selected for this clinical study. The patients between the age group of 20-60 years of age will be selected. The assessment of the trial will be done on the basis of subjective and objective parameters. The period of study is 18 months and duration of study is 2 months. Data depending upon above subjective and objective criteria and other variables will be collected and analysed statistically. |