| CTRI Number |
CTRI/2025/11/097675 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to see the effect of Ayurvedic medicines Bhumyamalaki Vati and Shyonaka Hima along with standard treatment in patients with chronic hepatitis B |
|
Scientific Title of Study
|
Clinical evaluation of Bhumyamalaki vati and Shyonaka hima as an adjunct with the standard therapy in chronic Hepatitis B |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AKSHITA |
| Designation |
PG Scholar |
| Affiliation |
Quadra Institute Of Ayurveda And Hospital |
| Address |
Opd No 2 Department Of Kayachikitsa Quadra Institude Of Ayurveda And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School Roorkee
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9915780851 |
| Fax |
|
| Email |
akshitaprashar96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Bhushan Sharma |
| Designation |
Professor |
| Affiliation |
Quadra Institute Of Ayurveda And Hospital |
| Address |
Opd No 2 Department Of Kayachikitsa Quadra Institude Of Ayurveda And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School Roorkee
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9458636020 |
| Fax |
|
| Email |
Ayu.abhishek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AKSHITA |
| Designation |
PG Scholar |
| Affiliation |
Quadra Institute Of Ayurveda And Hospital |
| Address |
Opd No 2 Department Of Kayachikitsa Quadra Institude Of Ayurveda And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School Roorkee
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9915780851 |
| Fax |
|
| Email |
akshitaprashar96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akshita Opd No 2 Department Of Kayachikitsa Quadra Institude Of Ayurveda And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School Roorkee 247667 |
|
|
Primary Sponsor
|
| Name |
AKSHITA |
| Address |
Opd No 2 Department Of Kayachikitsa Quadra Institude Of Ayurveda And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School Roorkee 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 |
| AKSHITA |
Quadra Institude Of Ayurveda And Hospital |
Opd No 2 Department Of Kayachikitsa Quadra Institude Of Ayurveda And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL |
9915780851
akshitaprashar96@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:K739||Chronic hepatitis, unspecified. Ayurveda Condition: KUMBAKAMALA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Bhumyamalaki vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: shyonaka hima 80ml), Additional Information: -Fifteen patients will receive interventional treatment, while the other fifteen will be in the control group. | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard supportive Therapy(Conventional management) | Patients in the control group will receive standard supportive therapy for chronic Hepatitis B, which includes dietary advice, adequate rest, avoidance of hepatotoxic drugs, and use of hepatoprotective agents such as silymarin or vitamin supplements as per clinical need. Antiviral and immunosuppressive drugs will not be used in this group. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between the age group of 18 to 65 years.
2. Patients irrespective of sex, religion and occupation.
3. Patients with ALT levels ranging from the upper limit of normal to twice the upper limit of
normal 41 to 82 will be selected.
4. Patients with low level of HBV DNA will be selected less then 20,000IU/ml for HBeAg
positive patients and less then 2000IU/ml for HBeAg negative patients.
5. Patients with symptoms and signs of chronic hepatitis B and diagnosed chronic hepatitis B infection will be selected. |
|
| ExclusionCriteria |
| Details |
1. Concurrent infection with hepatitis C, D or other hepatic viral infection , autoimmune
hepatitis or alcoholic hepatitis.
2. Significant comorbidities such as liver cirrhosis, renal failure or cardiovascular diseases.
3. Pregnant or breastfeeding women.
4. Decompensated liver disease.
5. Patient suffering from Ascites, hepatic encephalopathy, variceal bleeding.
6. Hepatocellular carcinoma.
7. Patients who have previously taken Interferons or antiviral agents, Corticosteroids,immunosuppressive drug. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in HBV DNA levels with ALT normalization after treatment. |
Evaluation of reduction in viral load (HBV DNA) and ALT levels will be assessed at follow-up visits scheduled on the 30th, 60th, and 90th day after initiation of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of improvement in clinical symptoms, liver enzyme normalization trend, and overall quality of life; along with assessment of safety and tolerability of the intervention. |
18 months |
|
|
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)
|
20/11/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 open-label, two-arm randomized controlled trial aims to evaluate the efficacy of Bhumyamalaki Vati and Shyonaka Hima as an adjunct with the standard therapy in patients with chronic Hepatitis B who falls within the gray zone( indeterminate phase). Thirty patients aged 18–65 years with ALT levels ranging from 41-82U/L And a low level of HBV DNA, i-e less than 20,000IU/ml for HBeAg positive patients and less than 2000IU/ml for HBeAg negative patients, will be enrolled from the OPD and IPD of the Kayachikitsa Department, Quadra Institute of Ayurveda. Participants will be randomly allocated into two groups. One group will receive standard supportive therapy, while the other will receive standard supportive therapy along with the Ayurvedic intervention. The treatment duration will be 90 days, with a total study period of 18 months. Assessment will be based on subjective and objective parameters, and the collected data will be statistically analyzed to evaluate clinical efficacy. |