| CTRI Number |
CTRI/2026/01/101906 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on an Antioxidant Drink and Liver Health in Individuals Undergoing Alcohol Deaddiction |
|
Scientific Title of Study
|
A 12-Week Randomized Controlled Study on the Impact of an Antioxidant Drink on the liver profile Among Alcoholics in a Deaddiction Center in Koyambedu, Chennai |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavitha N |
| Designation |
Ph.D Research Scholar |
| Affiliation |
Department of Nutrition and Dietetics, Meenakshi Academy of Higher Education and Research, Chennai |
| Address |
Department of Nutrition and Dietetics,
Meenakshi Academy of Higher Education and Research,
No.12, Vembuliamman Koil Street,
West KK Nagar, Chennai – 600078
Department of Nutrition and Dietetics,
Meenakshi Academy of Higher Education and Research,
Chennai – 600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9381567889 |
| Fax |
|
| Email |
kavitha_res@maher.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Kavitha N |
| Designation |
Ph.D Research Scholar, Department of Nutrition and Dietetics |
| Affiliation |
Department of Nutrition and Dietetics, Meenakshi Academy of Higher Education and Research, Chennai |
| Address |
Department of Nutrition and Dietetics,
Meenakshi Academy of Higher Education and Research,
No.12, Vembuliamman Koil Street,
West KK Nagar, Chennai – 600078
Department of Nutrition and Dietetics,
Meenakshi Academy of Higher Education and Research,
Chennai – 600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9381567889 |
| Fax |
|
| Email |
kavitha_res@maher.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Kavitha N |
| Designation |
Ph.D Research Scholar, Department of Nutrition and Dietetics |
| Affiliation |
Department of Nutrition and Dietetics, Meenakshi Academy of Higher Education and Research, Chennai |
| Address |
Department of Nutrition and Dietetics,
Meenakshi Academy of Higher Education and Research,
No.12, Vembuliamman Koil Street,
West KK Nagar, Chennai – 600078
Department of Nutrition and Dietetics,
Meenakshi Academy of Higher Education and Research,
Chennai – 600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9381567889 |
| Fax |
|
| Email |
kavitha_res@maher.ac.in |
|
|
Source of Monetary or Material Support
|
| Recovery Home Foundation,
No. 169, 1st Cross Street,
Near Marthoma School,
Sri Ayyappa Nagar, Chinmaya Nagar,
Natesan Nagar, Koyambedu,
Chennai – 600092,
Tamil Nadu,
India.
Phone: 81228 84255
|
|
|
Primary Sponsor
|
| Name |
KAVITHA N |
| Address |
Meenakshi Academy of higher education and research
No 12 vembuliamman koil street
West KK Nagar
chennai 600078 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrVSureka Varalakshmi |
MEENAKSHI ACADEMY OF HIGHER EDUCATION AND RESEARCH |
No12 Vembuliamman Koil Street West Kknagar Chennai 600 078
Chennai
TAMIL NADU |
9895099463
surekaramesh.v@gmail.com |
| Dr Saranya |
Recovery Home Foundation |
Deaddiction and Rehabilitation Unit,
Residential Care Section,
No. 169, 1st Cross Street,
Near Marthoma School,
Sri Ayyappa Nagar, Chinmaya Nagar,
Natesan Nagar, Koyambedu,
Chennai – 600092,
Tamil Nadu, India
Chennai
TAMIL NADU |
7639701658
info@recoveryhomedeaddictioncentre.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEENAKSHI ACADEMY OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PARTICIPANTS IN THE DEADICTION CENTRE WITH ABNORMAL LIVER PROFILE |
| Patients |
(1) ICD-10 Condition:K700||Alcoholic fatty liver. Ayurveda Condition: Alcoh, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: antioxidant drink, Reference: NA, Route: Oral, Dosage Form: , Dose: 100(ml), Frequency: od, Bhaishajya Kal: Grasa bhakta/Sagrasa, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | N/A | Participants will receive standard care only as per the deaddiction center protocol without antioxidant supplementation for 12 weeks. |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Male |
| Details |
Participants residing in a deaddiction centre with elevated liver parameters and fatty liver.
Adults aged eighteen to fifty eight years.
Individuals diagnosed with alcohol dependence and currently undergoing rehabilitation.
Participants willing to provide written informed consent.
Medically stable individuals who are capable of participating in a twelve week intervention program. |
|
| ExclusionCriteria |
| Details |
Diagnosed liver cirrhosis or severe hepatic insufficiency.
Co-morbid psychiatric conditions requiring medication.
Known allergy to any ingredient in the antioxidant drink.
Currently on nutrition supplements or herbal medications
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess whether a natural antioxidant drink (fermented rice water, amla, ginger, mint, coriander, curry leaves) can reduce liver damage and improve liver function using liver enzymes and relevant biomarkers. |
Baseline, 4 weeks, 8 weeks, and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of the natural antioxidant drink on To assess the effect of the natural antioxidant drink (fermented rice water, amla, ginger, mint, coriander, curry leaves) on reducing LDL cholesterol & improving liver stiffness in participants with fatty liver. |
Baseline four weeks eight weeks & twelve weeks. |
| THERE IS REDUCTION IN THE LDL LEVEL AND IMPROVEMENT IN THE LIVER STIFFNESS DUE TO FATTY LIVER |
|
|
|
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 |
|
Date of First Enrollment (India)
|
25/02/2026 |
| 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="4"
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
|
participants are invited to participate in a research study being conducted to evaluate whether a specially prepared antioxidant drink can help improve liver function in individuals recovering from alcohol dependency. Participation in this study is completely voluntary and may choose to withdraw at any time without affecting your ongoing treatment or care. |