| CTRI Number |
CTRI/2024/12/078032 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial of Manadha gutika and Vasadi kwath in the treatment of Fatty Liver |
|
Scientific Title of Study
|
A clinical study of Manadha Gutika and Vasadi Kwath in the management of Yakrit Vikar w.s.r. to Fatty Liver
|
| 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 Abhishek Kumar Tyagi |
| Designation |
PG Scholar |
| Affiliation |
Govt Dhanwantri Ayurved Medical College And Hospital Ujjain Madhyapradesh |
| Address |
OPD No 28 Kayachikitsa Department Govt Dhanwantri Ayurved Hospital Ujjain Madhyapradesh
Ujjain
MADHYA PRADESH
456010
India |
| Phone |
9827344295 |
| Fax |
|
| Email |
tyagiabhishek83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Saraf |
| Designation |
Reader |
| Affiliation |
Govt Dhanwantri Ayurved Medical College And Hospital Ujjain Madhyapradesh |
| Address |
OPD No 28 Kayachikitsa Department Govt Dhanwantri Ayurved Hospital Ujjain Madhyapradesh
Ujjain
MADHYA PRADESH
456010
India |
| Phone |
8085740020 |
| Fax |
|
| Email |
vandana13ishnavi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Kumar Tyagi |
| Designation |
PG Scholar |
| Affiliation |
Govt Dhanwantri Ayurved Medical College And Hospital Ujjain Madhyapradesh |
| Address |
OPD No 28 Kayachikitsa Department Govt Dhanwantri Ayurved Hospital Ujjain
Ujjain
MADHYA PRADESH
456010
India |
| Phone |
9827344295 |
| Fax |
|
| Email |
tyagiabhishek83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rasshala govt dhanwantri ayurved medical college ujjain Madhyapradesh INDIA pin 456001 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Abhishek Kumar Tyagi |
Govt Dhanwantri Ayurveda Hospital Ujjain Madhyapradesh |
OPD No 28 Kayachikitsa Department
Ujjain
MADHYA PRADESH |
9827344295
tyagiabhishek83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVT DHANWANTRI AYURVEDA MEDICAL COLLEGE UJJAIN MADHYAPRADESH MEDICAL SCIENCE UNIVERSITY JABALPUR MADHYAPRADESH |
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 | Classical | | (1) Medicine Name: Manadha Gutika, Reference: Chakradutta Plihayakrit Rog Chikitsa 13/15-16-17, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Ushnodaka), Additional Information: -nil | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vasadi Kwath, Reference: Ashtanga Hridaya Chikitsa Adhyay 16/13, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -nil | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manadha Gutika, Reference: Chakradutta Plihayakrit Rog Chikitsa 13/15-16-17, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Ushnodaka), Additional Information: -nil(2) Medicine Name: Vasadi Kwath, Reference: Ashtanga Hridaya Chikitsa Adhyay 16/13, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -nil |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with classical sign & symptoms as described in Ayurvedic and Modern medicine.
2. Patients willing to sign the consent form.
3. Abnormal Liver Function Tests.
4. Both sex groups randomly selected and patient with history of Fatty Liver less than 1year.
5. USG findings suggestive of fatty liver grade 1 and grade 2
|
|
| ExclusionCriteria |
| Details |
1. Patient below 18 year and above 60 years of age group & Pregnant females.
2. Patient having chronic heart disease, chronic renal failure, hepatocellular or any other carcinoma, tuberculosis, portal vein obstruction, biliary obstruction, ascitise.
3. Alcoholic fatty liver disease, any infective liver disorder, hypertension, diabetes mellitus and any surgery.
4. Drug addicts’ rapid deterioration, who lapsed into coma and bleeding tendencies.
5. Patients consuming hepatotoxic medicines, Alcohol or other Narcotic substances.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in USG, LFT and Lipid Profile Findings |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in Symptoms likes DAURBALYA (WEAKNESS)
AROCHAK (LACK OF APPETITE)
VARCHOMOOTRAGRAH (CONSTIPATION)
PIPASA (THIRST)
CHARDI (VOMITING)
MRUDU JWAR (LOW GRADE FEVER)
AANAHA (FLATULANCE)
HEPATOMEGALY
HEPATIC TENDERNESS & DULL ACHE
PALLOR
EXCESSIVE SWEATING
MENTAL CONFUSION |
60 Days |
|
|
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)
|
23/12/2024 |
| 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 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
|
Fatty liver is no longer strange to us especially
now-a-days in the society. Fatty liver refers as the accumulation of fat in the
liver that can cause inflammation and gradually decrease in liver function.
Fatty liver is a metabolic disorder. Fatty liver is an important cause of
chronic liver disease and should be treated in early condition. Liver
disorder one of the major problems and it is among the top ten cause of death
in the world. According
to the latest WHO data published in 2020 liver disease deaths in India reached
268,580 or 3.17% of total deaths. The
prevalence of fatty liver in India is 9-32% with an average of 25% in general
population. The
holistic concepts of Ayurveda give emphasis to health promotion, disease
prevention, early diagnosis and personalized treatment even in Liver care. Ayurvedic preparation Manadha Gutika and Vasadi Kwath is adopted for the treatment of fatty Liver.
|