| CTRI Number |
CTRI/2025/08/092541 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Helping You Burn Fat Naturally Results from a Human Trial of Zeroharm fat burner Tablets |
|
Scientific Title of Study
|
clinical study to evaluate the Efficacy of Fat Burner in the management of obesity |
| 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 Pranabjyoti Baishya |
| Designation |
Principal HOD |
| Affiliation |
Government Ayurvedic College, Jalukbari, Guwahati -14 , Assam |
| Address |
Department of Rachana Sharir (Anatomy) Govt Ayurvedic college
Kamrup
ASSAM
781014
India |
| Phone |
8822376327 |
| Fax |
|
| Email |
drpjbaishya1967@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranabjyoti Baishya |
| Designation |
Principal HOD |
| Affiliation |
Government Ayurvedic College, Jalukbari, Guwahati -14 , Assam |
| Address |
Department of Rachana Sharir (Anatomy) Govt Ayurvedic college
ASSAM
781014
India |
| Phone |
8822376327 |
| Fax |
|
| Email |
drpjbaishya1967@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranabjyoti Baishya |
| Designation |
Principal HOD |
| Affiliation |
Government Ayurvedic College, Jalukbari, Guwahati -14 , Assam |
| Address |
Department of Rachana Sharir (Anatomy) Govt Ayurvedic college
ASSAM
781014
India |
| Phone |
8822376327 |
| Fax |
|
| Email |
drpjbaishya1967@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Zeroharm Sciences Private Limited 3rd Floor Unit B-23 Phase - II, Technocrat Industrial Estate Balanagar Hyderabad Telangana 500037 |
|
|
Primary Sponsor
|
| Name |
Zeroharm Science Private Limited |
| Address |
Unit No. B 23, Phase 2 Technocrat, Cooperative Industrial Estate, Balanagar, Hyderabad, Telangana, Pin 500037, India |
| Type of Sponsor |
Other [Neutracutical Company ] |
|
|
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 Pranabjyoti Baishya |
Government Ayurvedic College and Hospital |
Department of Rachana Sharir (Anatomy), Jalukbari Guwahti Assam Pin 781014 India
Kamrup
ASSAM |
8822376327
drpjbaishya1967@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Govt Ayurvedic College Jalukbari Guwahati Assam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Zeroharm fat burner, 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: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
subjects having BMI more than 30 kg/m2 and lower than 40 kg/m2
Subjects not suffering from any significant illness (medical or surgical)
Subjects not not currently taking weight loss medications or supplements |
|
| ExclusionCriteria |
| Details |
Subjects below 18 years or above 60 years of age
Patient having very high level of dyslipidaemia
Individuals with a history of cardiovascular disease, liver or kidney dysfunction, or those taking medications affecting weight. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in body weight and fat mass. Result will be assessed on the basis of body weight, BMI, Body circumference measurements of certain regions. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Changes in metabolic markers (blood glucose, lipid profile, inflammatory markers) 2.Assessment of appetite and satiety (using validated questionnaires). 3. Evaluation of side effects and overall safety through regular monitoring. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
A clinical study will be conducted to assess the efficacy and safety of Zeroharm Fat Burner tablets, an Ayurvedic formulation, in individuals with obesity. Eligible participants will be administered the tablets daily for a period of three months. Two follow-up visits will be scheduled at 1-month intervals to monitor patient progress. Baseline and post-treatment laboratory tests will be conducted to evaluate clinical outcomes. Key parameters will include body weight, BMI, waist circumference, lipid profile, and metabolic markers. Changes in appetite, energy levels, and physical activity tolerance will also be recorded. The study will monitor for any adverse effects and ensure patient safety throughout. Patient compliance and tolerability of the Ayurvedic formulation will be assessed. Data will be statistically analyzed to determine the effectiveness of the treatment. The study aims to validate Zeroharm Fat Burner as a safe and natural aid for weight management. |