| CTRI Number |
CTRI/2022/07/043836 [Registered on: 07/07/2022] Trial Registered Prospectively |
| Last Modified On: |
06/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic Treatment For Yakrita Vikara (Fatty Liver Disorders) |
|
Scientific Title of Study
|
ROLE OF ROHITAKADI VATI IN YAKRITA VIKARA (NON-ALCOHOLIC FATTY LIVER DISEASE) |
| Trial Acronym |
RRVYV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shweta Rawat |
| Designation |
P.G Scholar |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University |
| Address |
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurved University Haridwar
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9761498099 |
| Fax |
|
| Email |
shwetarawat0007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kumar Tripathi |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University |
| Address |
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurved University Haridwar M-60 Harilok Colony Jwalapur Haridwar
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9568004650 |
| Fax |
|
| Email |
sanjaytripathi.230@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Kumar Tripathi |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University |
| Address |
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurved University Haridwar M-60 Harilok Colony Jwalapur Haridwar
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9568004650 |
| Fax |
|
| Email |
sanjaytripathi.230@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Shweta Rawat, P.G Department of Kayachikitsa Rishikul Campus Haridwar |
|
|
Primary Sponsor
|
| Name |
Dr Shweta Rawat |
| Address |
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurved University Haridwar 249401 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shweta Rawat |
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurved University Haridwar 249401 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Rawat |
Rishikul Campus Uttarakhand Ayurved University Haridwar |
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL |
09761498099
shwetarawat0007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttarakhand Ayurveda University |
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: Yakrita Vikara, (2) ICD-10 Condition:K77||Liver disorders in diseases classified elsewhere. Ayurveda Condition: Yakrita Vikara, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rohitakadi Vati, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Ushna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with clinical sign and symptom of Yakrita Vikara (Non-alcoholic fatty liver disease) are Aruchi, Hrillasa, Avipaka, Daurbalya, Udara shoola, Asya-vairasya, Anaha.
2. Fatty Liver Grade-1 and Grade-2 based on USG.
3. Liver function test showing raised Alanine amini transferase more than 1.5 times the normal limits.
4. Prediabetic patients. |
|
| ExclusionCriteria |
| Details |
1.Age group <20 years and >60 years.
2.Chronic Renal Failure, Ischemic heart disease, Congestive cardiac failure, Liver cirrhosis, AIDS.
3.Pregnancy and Lactation.
4.Prolonged medication for various systemic disorders.
Grade-3 Fatty Liver.
SGPT>100 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of Yakrita Vikara (Non-alcoholic fatty liver disease) are Aruchi, Avipaka, Hrillasa, Daurbalya, Udara shoola, Asya-vairsya, Anaha. |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Liver function test and USG. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
11/07/2022 |
| 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)?
Response - NO
|
|
Brief Summary
|
In Ayurveda,Liver play an important role as Chaya-upachayay, Ranjana of Rasa Dhatu, Storage and detoxification to keep body healthy. Due to Western Lifestyle Disorders, Agni play major role in manifestation of diseases such as Yakrita vikara (Non-alcoholic fatty liver disease). Ayurveda describes Liver disease in context of Yakrita Vikara . These concepts can be applied to fatty liver also. Nowadays NAFLD so common. Symptoms are loss of appetite, Indigestion, Nausea, Abdominal pain, Altered taste in mouth. The drug chosen for study is Rohitakadi vati described in Bhaishajya Ratnavali having Rechana *Purgative), Lekhana, Agnivardhaka, Ama, Medha Kapha nasak qualities. |