| CTRI Number |
CTRI/2023/10/058382 [Registered on: 06/10/2023] Trial Registered Prospectively |
| Last Modified On: |
05/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, Shigru kwatha and Livogrit in patients with Non Alcoholic Fatty Liver Disease |
|
Scientific Title of Study
|
A Comparative Clinical Study of Shigru Kwatha and Livogrit in Yakritvikara (Non Alcholic 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 Rajan Dalel |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand 249405, India |
| Address |
Department of Kayachikitsa, OPD no.13/14, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand 249405, India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8532994444 |
| Fax |
|
| Email |
rajandalel0404@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C B Dhanraj |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand |
| Address |
Department of Kayachikitsa, OPD no.13/14, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand 249405, India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
917396174582 |
| Fax |
|
| Email |
drcbdhanraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C B Dhanraj |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand |
| Address |
Department of Kayachikitsa, OPD no.13/14, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand 249405, India
UTTARANCHAL
249405
India |
| Phone |
917396174582 |
| Fax |
|
| Email |
drcbdhanraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar 249405 uttarakhand |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrRajan Dalel |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Department of kayachikitsa, OPD no. 13/14, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan.
Hardwar
UTTARANCHAL |
8532994444
rajandalel0404@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Institutional ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K759||Inflammatory liver disease, unspecified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Livogrit, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shigru kwatha , Reference: Chakradutt udar chikitsa chapter 37 shloka 44 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient between the age group of 18 to 65 years will be selected.
2. Patient irrespective of gender, religion, occupation and chronicity will be selected for the study.
3. Both fresh and treated cases would be taken for the study.
4. Patient with Grade 1 and Grade 2 fatty liver only will be selected for the study.
5. Individual with controlled Diabetes Mellitus having Grade 1 and Grade 2 fatty liver will be selected for the study. |
|
| ExclusionCriteria |
| Details |
1.Pregnant or lactating women will be excluded.
2. Patient who have had Hepatitis B,C or other hepatic viral infection , autoimmune hepatitis and drug induced hepatitis or alcoholic hepatitis will be excluded.
3. Patient with severe complication of the cardiovascular, renal or hematopoietic systems and mental disease will be excluded.
4. Patient will be excluded having decompensated liver disease.
5. Patient with prolonged or a history of ascites , developed Hepatocellular carcinoma Hepatic Encephalopathy , Variceal bleeding will be excluded.
6. Patient with a history of using IFN or antiviral agents or Corticosteroids or Immunosuppresive drugs will also be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective criteria
1. Anorexia
2. Fatigue
3. Abdominal pain
4. Malaise
5. Indigestion(avipaka)
6. Polydipsia (pipasa)
7. Constipation
8. Vomiting (chhardi)
9. Fever (mridu jwara)
10. Flatulence (aanaha)
11. Tastelessness |
0th day 30th day 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objective Criteria
1. Ultrasonography whole abdomen
|
0th day 60th day |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/10/2023 |
| 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 Yet Recruiting |
| 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 study is a open label double arm comparative study , comparing the efficacy of Shigru Kwatha 100 ml twice daily before meal and Livogrit tablet each 500mg 2 tablet twice daily before meal in 40 patients with Yakritvikara that will be conducted in OPD no. 13/14 in Patanjali Ayurvedic hospital, Haridwar. Assessment will be done on the basis of subjective and objective parameter. Route of administration- Oral Route
Follow up- follow up will be done to observe effects of treatment or any adverse effect on the patient. |