| CTRI Number |
CTRI/2020/07/026362 [Registered on: 04/07/2020] Trial Registered Prospectively |
| Last Modified On: |
30/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [management] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the efficacy of Sarvakalpa-ghan-vati in management of non-alcoholic liver disorder. |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF THE THERAPEUTIC EFFICACY OF SARVAKALPA-GHAN-VATI IN NON-ALCOHOLIC LIVER DISORDER. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gyanendra Datta Shukla |
| Designation |
Associate Professor |
| Affiliation |
Uttarakhand AyurVed university, Gurukul College Haridwar |
| Address |
Department of Panchkarma, Uttarakhand AyurVed university, Gurukul College Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
8791265576 |
| Fax |
|
| Email |
dr.gdshukla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhuvnesh Sharma |
| Designation |
P.G. Scholar |
| Affiliation |
Uttarakhand AyurVed university, Gurukul College Haridwar |
| Address |
Department of panchkarma, Uttarakhand ayurved university, Gurukul college Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
7838845357 |
| Fax |
|
| Email |
ayurveda.nature@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhuvnesh Sharma |
| Designation |
P.G. Scholar |
| Affiliation |
Uttarakhand AyurVed university, Gurukul College Haridwar |
| Address |
Department of Panchkarma,Uttarakhand ayurved university, Gurukul college Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
7838845357 |
| Fax |
|
| Email |
ayurveda.nature@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Institute, Hardwar, Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Institute |
| Address |
Patanjali Research institute , Haridwar-249405 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Bhuvnesh sharma |
Gurukul Campus |
Department of Panchkarma Gurukul College, Uttarakhand Ayurved University, Haridwar
Hardwar
UTTARANCHAL |
7838845357
ayurveda.nature@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo will be given to patient |
Group B: In this group, Placebo will be given to patients orally along with Pathyasevan and life style modification for two months |
| Intervention |
Sarvakalpghan vati |
ï¶ Group A: Use of Sarvakalpa-Ghan-Vati 2 tablet twice daily,orally, associated with Pathyasevan and life style modification for two months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients between the age group of 18-65 years will be selected.
2)Patients irrespective of sex, religion, occupation and chronicity will be selected for the study.
3)Both fresh and treated cases would be taken for the study.
4)Patients with higher LFT levels than the upper limit of normal value will be selected.
5)Patients with GRADE 1 and GRADE 2 fatty liver will be selected for the study.
6)Patient with controlled Diabetes mellitus having GRADE 1 and GRADE 2 fatty liver will be selected for the study.
|
|
| ExclusionCriteria |
| Details |
1)Patients aged <18 years or >65 years will be excluded.
2)Pregnant or lactating women will be excluded.
3)Patients who had hepatitis B, C or other hepatic viral infection, autoimmune hepatitis and drug-induced hepatitis or alcoholic hepatitis will be excluded.
4)Patients with severe complications of the cardiovascular, renal or hematopoietic systems and mental diseases will be excluded.
5)Patients will be excluded having decompensated liver disease.
6)Patients with prolonged or a history of ascites, developed hepato-cellular carcinoma, hepatic encephalopathy, variceal bleeding will be excluded.
7)Patients with a history of using IFN or antiviral agents or corticosteroids or immunosuppressive drugs will also be excluded.
8)Patients having GRADE 3 fatty liver disease will be excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| normalisation of LFT values |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exacerbation in Signs & Symptoms. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
TRIAL NOT YET STARTED |