| CTRI Number |
CTRI/2024/12/077731 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Test if Liver Detox Formula is Safe and Works for Treating Patients with Fatty Liver Disease |
|
Scientific Title of Study
|
An Open-Label Study To Evaluate The Safety And Efficacy Of Liver Detox Formula In Fatty Liver Disease |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2419 Version No. 1.0 Dated 04/Oct/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr BN Satish |
| Designation |
Principal Investigator |
| Affiliation |
RVS Ayurvedic Medical College, Hospital and Research Centre |
| Address |
RVS Ayurvedic Medical College, Hospital and Research Centre, Srigandhadakavalu, Vishwaneedam Post, Outer Ring Road,
Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
drsatish.clinical@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. Vikram Chauhan |
| Designation |
Managing Director |
| Affiliation |
Planet Ayurveda Private Limited |
| Address |
Plot No. 627, JLPL,
Industrial Area, Sector-82,
Mohali, Punjab (India)
PUNJAB
160055
India |
| Phone |
8578888111 |
| Fax |
|
| Email |
trade@planetayurveda.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Arpita Malgi |
| Designation |
Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main,
Jayanagar 9th Block, Bangalore
Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Planet Ayurveda Private Limited, Plot No. 627, JLPL, Industrial Area,
Sector-82, Mohali-160055, Punjab, India. |
|
|
Primary Sponsor
|
| Name |
Planet Ayurveda Private Limited |
| Address |
Plot No. 627, JLPL, Industrial Area,Sector-82, Mohali-160055, Punjab, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 B N Satish |
RVS Ayurvedic Medical College, Hospital and Research Centre |
RVS Ayurvedic Medical College, Hospital and Research Centre, Srigandhadakavalu, Vishwaneedam Post, Outer Ring Road, Bangalore-560091.
Bangalore
KARNATAKA |
06364898825
drsatish.clinical@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PRANAV DIABETES CENTER ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K700||Alcoholic fatty liver. Ayurveda Condition: YAKRUDDALYUDARAH, (2) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Liver Detox Formula, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -The Liver Detox Formula study involves 50 participants taking 2 capsules daily after meals for a duration of 90 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis - Patients already diagnosed with Alcoholic Fatty Liver Disease (AFLD) or Non-Alcoholic Fatty Liver Disease (NAFLD) confirmed through clinical evaluation (e.g., imaging or medical history).
2. Willingness to Participate - Participants must be willing and able to provide written informed consent and comply with the study requirements, including completing all scheduled visits and questionnaires.
3. Stable Medical Condition - Participants should have a stable medical condition that would not interfere with the study treatment or outcome evaluations. |
|
| ExclusionCriteria |
| Details |
1. Severe Liver Disease - Patients with severe liver diseases, such as cirrhosis, hepatic failure, or hepatocellular carcinoma.
2. Pregnancy or Breastfeeding - Pregnant or breastfeeding women.
3. Other Liver Conditions - Patients diagnosed with liver conditions unrelated to fatty liver disease, including but not limited to Hepatitis B, Hepatitis C, or HIV.
4.Use of Other Investigational Drugs - Participants currently enrolled in another clinical study or using investigational drugs within 30 days prior to screening.
5. Severe Comorbidities - Patients with severe comorbid conditions such as uncontrolled cardiovascular, renal, or hematological diseases that could interfere with the study results or pose an increased risk to the patient.
6. Substance Abuse - Patients with a history of substance abuse (other than alcohol) or any medical condition that could affect compliance with the study protocol.
7. Non-compliance - Patients unable or unwilling to comply with study procedures, including attending follow-up visits or completing questionnaires. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Chronic Liver Disease Questionnaire (CLDQ)
2. Fatigue Severity Scale (FSS) |
Day 0, Day 30, Day 60 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improvement in Liver-Related Symptoms
2. Patient Satisfaction
3. Safety and Tolerability
4. Clinician-Assessed Symptom Improvement
5. Clinician Disease Severity Assessment |
Day 0, Day 30, Day 60 and Day 90. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2024 |
| Date of Study Completion (India) |
30/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
INTRODUCTION: Fatty Liver Disease (FLD) iis a prevalent condition marked by the accummulaton of fat in liver cells, which can lead to inflammation and liver damage. FLD is categorised into two primary types: Alcoholic Fatty Liver Disease (AFLD) due to excessive alcohol consumption and Non-Alcoholic Fatty Liver Disease (NAFLD), commonly associated with metabolic conditions like obesity, type 2 diabetes and sedentary lifestyle. Both of them if untreated can lead to serious liver issues such as fibrosis, cirrhosis and hepatocellular carcinoma. Currently, no specific drugs are approved to treat FLD. Liver Detox Formula is a traditional herbal supplement believed to enhance liver health. This study was planned to gather clinical data to prove the effectiveness of Liver Detox Formula in the treatment of AFLD and NAFLD.
PURPOSE: The primary purpose of the study was to evaluate the safety and efficacy of LIver Detox Formula as a complementary treatment for AFLD and NAFLD. The study aimed at improving liver-related symptoms and enhancing the Quality of Life in patients using a non-invasive patient-centered approach.
RESULTS: A total of 50 participants were enrolled, out of which 45 completed the study (25 male and 20 female participants). All the participants had normal vital signs throughout the study. The Efficacy analysis was conducted to assess the impact of Liver Detox Formula on liver health over a 90-day treatment period. Primary Efficacy Endpoints: Chronic Liver Disease Questionnaire (CLDQ) outcome revealed abdominal symptoms, fatigue, Systemic symptoms, Daily Limitations, Psychological Worries and Emotional Distress all improved significantly by 82.44%. P-values across all CLDQ domains ranged from 1.17E-57 to 2.29E-47 confirming extremely high statistical significance. Fatigue Sererity Scale (FSS): Fatigue severity improved by 85% from a baseline mean of 6.6 to 1.5 by Visit 4. P-value of 8.44E-62 indicated significant reduction in fatigue levels. The low standard deviation values supported improvement consistency across participants. Secondary Efficacy Endpoints: Symptom Specific Checklist - Significant improvement in gastrointestinal symptoms with an average of over 84% with P-value of 9.96E-35 indicating robust treatment effect with clinical significance. Chronic Disease Severity Assessment - Clinician-rated scores showed a >90% from visit 1 to 4 across all domains. P-value of 2.0E-52 confirmed uniform and substantial clinical recovery across the patient population. Clinician-Assessed Symptom Improvement - A 73.46% improvement noted in composite symptom ratings between Visit 2 and Visit 4. P-value of 1.02E-34 supported the sustained and reliable perception of recoveery by the clinical evaluators. No SAEs were reported and the product was well tolerated. There were no treatment discontinuations due to adverve events.
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