| CTRI Number |
CTRI/2025/04/083810 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study efficacy of Rohitak Abhaya Kwath in the management of Non Alcoholic Fatty Liver Disease |
|
Scientific Title of Study
|
A clinical study on the efficacy of Rohitak Abhaya Kwath in the management of 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 Neelim Shyam Bharali |
| Designation |
PG Scholar |
| Affiliation |
Govt Ayurvedic College & Hospital Guwahati |
| Address |
Dept of Kayachikitsa Govt Ayurvedic College and Hospital Guwahati
Kamrup
ASSAM
781014
India |
| Phone |
9954522422 |
| Fax |
|
| Email |
drneelim7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyamanta Kalita |
| Designation |
Associate Professor & Guide |
| Affiliation |
Govt Ayurvedic College & Hospital Guwahati |
| Address |
Dept of Kayachikitsa Govt Ayurvedic College and Hospital Guwahati
Kamrup
ASSAM
781014
India |
| Phone |
9707186463 |
| Fax |
|
| Email |
kalitashyamanta108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyamanta Kalita |
| Designation |
Associate Professor & Guide |
| Affiliation |
Govt Ayurvedic College & Hospital Guwahati |
| Address |
Dept of Kayachikitsa Govt Ayurvedic College and Hospital Guwahati
Kamrup
ASSAM
781014
India |
| Phone |
9707186463 |
| Fax |
|
| Email |
kalitashyamanta108@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurvedic College and Hospital Guwahati 781014 |
|
|
Primary Sponsor
|
| Name |
Dr Neelim Shyam Bharali |
| Address |
Govt. Ayurvedic College and Hospital Jalukbari Guwahati 781014 |
| 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 |
| Dr Neelim Shyam Bharali |
Govt Ayurvedic College & Hospital Guwahati-14 |
OPD & IPD of Dept. of Kayachikitsa, Govt Ayurvedic College and Hospital Jalukbari Guwahati-14
Kamrup
ASSAM |
9954522422
drneelim7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Govt Ayurvedic College and Hospital, Jalukbari, Guwahati |
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 | Comparator Arm (Non Ayurveda) | | - | Ursodeoxycholic Acid | Dose: 300 mg BiD
Duration: 45 days
Route: Oral | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rohitak Abhaya Kwath, Reference: Chakradatta Chapter 38, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between 18 to 70 years of age irrespective of the sex.
2. Subjects having complaints of indigestion, pain abdomen, anorexia, fatigue,
nausea and fulfilling the criteria of diagnosis.
3. Non alcoholic fatty liver- Grade I, Grade II and Grade III |
|
| ExclusionCriteria |
| Details |
1. Subjects below 18 years more than 70 years.
2. Pregnancy and lactating mother
3. Any cardiac problem
4. Psychiatric disorders.
5. Stomach ulcer
6. Cancer patients
7. Surgical intervention if any.
8. CLD patients with Ascites |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effectiveness of Rohitak Abhaya Kwath in the management of
symptomatology of NAFLD |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Rohitak Abhaya Kwath with Ursodeoxycholic Acid on LFT, USG WA and Lipid Profile |
15th, 30th and 45th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
12/04/2025 |
| 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="0"
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 a clinical study of Rohtak Abhaya Keats in management of Non Alcoholic Fatty Liver Disease. This study is done as a mandatory Post graduation thesis work. Total number of 60 patients will be studied for 45 days each. |