| CTRI Number |
CTRI/2025/07/091384 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving Liver Function Naturally: A Study on Holo Liver Detox |
|
Scientific Title of Study
|
A clinical study to evaluate the Efficacy of Holo Liver Detox in the management of Liver disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTarali Baruah |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College and Hospital, Jalukbari, Guwahati |
| Address |
Department of Rachana Sharir Government Ayurvedic College and Hospital Jalukbari Guwahati
Government Ayurvedic College and Hospital, Jalukbari, Guwahati
Kamrup
ASSAM
781014
India |
| Phone |
8011217519 |
| Fax |
|
| Email |
Taralibaruah80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTarali Baruah |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College and Hospital, Jalukbari, Guwahati |
| Address |
Department of Rachana Sharir Government Ayurvedic College and Hospital Jalukbari Guwahati
Government Ayurvedic College and Hospital, Jalukbari, Guwahati
ASSAM
781014
India |
| Phone |
8011217519 |
| Fax |
|
| Email |
Taralibaruah80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrTarali Baruah |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College and Hospital, Jalukbari, Guwahati |
| Address |
Department of Rachana Sharir Government Ayurvedic College and Hospital Jalukbari Guwahati
Government Ayurvedic College and Hospital, Jalukbari, Guwahati
ASSAM
781014
India |
| Phone |
8011217519 |
| Fax |
|
| Email |
Taralibaruah80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Zeroharm Sciences Private Limited, Hyderabad, Telangana, India PIN:500037 |
|
|
Primary Sponsor
|
| Name |
Zeroharm Sciences Private Limited |
| Address |
Unit No. B 23, Phase 2 Technocrat, Cooperative Industrial Estate, Balanagar, Hyderabad, Telangana, Pin 500037, India |
| Type of Sponsor |
Other [Neutracutical company ] |
|
|
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 |
| DrTarali Baruah |
Govt. Ayurvedic College & Hospital |
Govt. Ayurvedic College and Hospital, Jalukbari Guwahti Assam, Pin- 781014, India
Kamrup
ASSAM
Kamrup
ASSAM |
08011217519
Taralibaruah80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Govt Ayurvedic College Jalukbari Guwahati Assam |
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: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Holo Liver detox, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who are diagnosed with fatty liver
2. Subjects having complaints of indigestion, pain abdomen, anorexia, fatigue, nausea and fulfilling the criteria of diagnosis
3.Subjects not suffering from any significant illness
4. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form. |
|
| ExclusionCriteria |
| Details |
Pregnant or Lactating females
Subjects with any cardiac pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessment criteria based on scoring (0-4) Yakritvriddhi (Enlargement of Liver), Avipaka (Indigestion), Angamarda (Bodyache), Vaman (Vomiting), Anaha (Distension), Dourbalya (Generalized Weakness), Udarshool (Abdominal Pain)
Aruchi (Loss of Appetite), Mandagni (Weak Digestive System) |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Investigations
1. Ultrasound of the Gallbladder and Abdomen (USGW/A)
2. Hematological Tests
Liver Function Tests (LFT)
Lipid Profile |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
The eligible patients of fatty liver will be treated with Holo Liver detox from Zeroharm Sciences Private Limited an ayurvedic medicine for a duration of three months. Two follow ups will be carried out at the interval of 1 month. Before and After the treatment, laboratory investigations will be carried out to find out the improvements of the patients. |