| CTRI Number |
CTRI/2024/07/070820 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the efficacy of Navanga Kwath with Vitamin E in the management of Non-Alcoholic Fatty Liver Disease(Yakritroga) |
|
Scientific Title of Study
|
A randomized open-labelled comparative clinical study to evaluate the efficacy of Navanga Kwath with Vitamin E in the management of Non-Alcoholic Fatty Liver Disease(Yakritroga) |
| 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 DIVYA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Institute for Ayurved studies and research SKAU Kurukshetra |
| Address |
Room no 56, Department of Kayachikitsa
Kurukshetra
HARYANA
136118
India |
| Phone |
7497839630 |
| Fax |
|
| Email |
divya.goyal595@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Neha Lamba |
| Designation |
Associate Professor |
| Affiliation |
Institute for Ayurved studies and research SKAU Kurukshetra |
| Address |
Room no 56, Department of Kayachikitsa
Kurukshetra
HARYANA
136118
India |
| Phone |
9736333868 |
| Fax |
|
| Email |
drlamba.neha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Divya |
| Designation |
Post Graduate Student |
| Affiliation |
Institute for Ayurved studies and research SKAU Kurukshetra |
| Address |
Room no. 56, Department of Kayachikitsa
Kurukshetra
HARYANA
136118
India |
| Phone |
7497839630 |
| Fax |
|
| Email |
divya.goyal595@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved studies and research sector 8 Umri road kurukshetra 136118 |
|
|
Primary Sponsor
|
| Name |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
Institute for Ayurved studies and research sector 8 Umri road kurukshetra 136118 |
| Type of Sponsor |
Government 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 |
| Dr Divya |
Institute for Ayurved studies and research |
Room no 56, Department of Kayachikitsa
Kurukshetra
HARYANA |
7497839630
divya.goyal595@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush 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: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Navanga Kwath , Reference: Bhaisajyaratnavali, Jvara-chikitsa- prakarana, 157, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 42 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Vitamin E | 400 mg, per oral, twice daily, for 42 days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The patient presented with cardinal features of Yakritroga as described in Ayurvedic
texts.
2. Randomly selected irrespective of their caste, religion and sex.
3. Patient with the age group of age of 25-60 years.
4. Voluntary agreement & and enrolment to participate in the study.
5. The ratio of AST/ALT below 2.
6. Non-alcoholic Fatty Liver Disease patient who was diagnosed by abdomen ultrasonic
examination and non-drinker or total abstainer or with alcohol intake of less than 20 gm
per day for females and less than 30 gm per day for males.
7. NAFLD confirmed by USG with or without having symptoms like fatigue and mild
discomfort in the upper quadrant of the abdomen.
8. Both freshly detected & and previously diagnosed cases of NAFLD. |
|
| ExclusionCriteria |
| Details |
1 Patient below 25 years and above 60 years of age
2 The ratio of AST or ALT over 2
3 Metabolic syndromes such as Type I and II Diabetes Mellitus Hypertension
Cerebrovascular Accident Myocardial Infarction and Chronic Kidney Disease
4 Any dysfunction of the liver besides Non Alcoholic Fatty Liver Diseases like Viral Hepatitis Liver Parenchymal Disease Ascites portal Hypertension Hepato Cellular Carcinoma Auto Immune Hepatitis Primary Biliary Cirrhosis Wilsons Disease and liver Transplantation or any other conditions interfering with the result of the treatment of non alcoholic fatty liver disease patient
5. Prior treatment with any medicine that affects the treatment of Non Alcoholic Fatty Liver Disease within 3 months
6 Patient suffering from HIV TB other infectious diseases Malignancies Major
Psychiatric Problems or any other serious problems
7. Patient on prolonged (more than 6 weeks) medication with corticosteroids antidepressants anticholinergic hepatotoxic medicines or any other drug that may influence the outcome of The study
8 Alcoholics and any other drug abusers
9 Pregnant and Lactating women
10 The patient has a history of Hypersensitivity to the trial drug or any of its ingredients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in scoring pattern of sign and symptoms such as Tastelessness, Indigestion, Mild pain in the upper abdomen, Feeling of heaviness, Diminution of the agni, Feeling of nausea and vomiting, Fatigue |
42 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in haematological parameters such as Serum cholestrol, Serum trigylcerides, SGPT, SGOT, Alkaline Phosphatase |
70 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)
|
04/08/2024 |
| 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="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
|
Non–alcoholic fatty liver disease represents a spectrum of liver disease encompassing simple fatty infiltration, inflammation and cirrhosis, in the absence of excessive alcohol consumption. The global prevalence of NAFLD is estimated to 24%. Vitiation of agni caused by Raktadhatu Dushti and Kapha dosha leads to formation of ama rasa or apakva anna rasa. Kapha dushti causes impaired metabolism of fat resulting in the deposition of excessive fat (Medas) in the liver. Most common symptoms such as Avipaka, Agnimandya, Aruchi, Utklesha, Mandavyatha, Gaurvanvita, etc. Based on all these signs and symptoms of NAFLD patients it can be correlated with Agnivikrita, Yakritroga and Medodushti vikara. Through the proper administration of Ayurvedic treatment protocol along with life style modification progression of this disease can be prevented. Accordingly, a study will be conducted with the aim to compare the efficacy of Navanga Kwatha and Vitamin E in the management of NAFLD (Yakritroga) for which 60 patients will be randomly selected and divided into two groups. In group A (30 patients) 24 ml of Navanga Kwatha (Intervention) will be given after meal three times a day for 42 days. In group B (30 patients) 400mg Vitamin E will be given with water after meal twice a day for 42 days. Patient will be regularly followed up on 0th, 7th, 14th, 21th, 28th, 35th, 42th (during treatment) and 56th and 70th day (post treatment). Clinical features and laboratory parameters will be analyzed during and after treatment and result will be analyzed using appropriate statistical methods. |