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CTRI Number  CTRI/2025/10/095664 [Registered on: 06/10/2025] Trial Registered Prospectively
Last Modified On: 29/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to Evaluate the Efficacy and Safety of Antox-D Liquid in People with Type 2 Diabetes 
Scientific Title of Study   A randomized, double-blind, parallel-arm clinical trial to assess the efficacy and safety of a Health supplement (Antox-D liquid) in participants with type 2 diabetes mellitus. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/25-26/007 Version: 2.00; dated 31st July 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anuja Mukesh Phalak 
Designation  Principal Investigator 
Affiliation  Omkar Multispecialty Hospital 
Address  Omkar Multispecialty Hospital Survey No 94, Plot No 81, opposite to Yashada Windosong, Ravet, Pune, Pimpri-Chinchwad, Maharashtra
-
Pune
MAHARASHTRA
412101
India 
Phone  9960789068  
Fax  -  
Email  anujarnp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pradeep Patil 
Designation  Partner 
Affiliation  Improva Herbal Products 
Address  Gat No. 112, Murhe Vasti, At Post Kuruli Tal Khed Dist Pune, Maharashtra
-
Pune
MAHARASHTRA
410501
India 
Phone  9823652100  
Fax  -  
Email  improvaherbal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sadik Shaikh 
Designation  Director 
Affiliation  Nutrifeel Health Products Pvt. Ltd 
Address  At post: Kundalwadi, Tal: Walva, Sangli, Maharashtra.
-
Sangli
MAHARASHTRA
415411
India 
Phone  7218977575  
Fax  -  
Email  sadikshaikh7575@gmail.com  
 
Source of Monetary or Material Support  
Improva Herbal Products Gat No. 112, Murhe Vasti, At Post Kuruli Tal Khed Dist Pune 410501, Pune, Maharashtra 
 
Primary Sponsor  
Name  Nutrifeel Health Products Pvt. Ltd 
Address  At post: Kundalwadi, Tal: Walva, Sangli, Maharashtra, 415411. 
Type of Sponsor  Other [Nutraceutical] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  - 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dnyaneshwar Manwatkar  Care multispeciality hospital  Kolte arcade, Nagar Rd, Wagholi, Pune, Maharashtra 412207
Pune
MAHARASHTRA 		 7769068455
-
dsmanwatkar31@gmail.com 
Dr Anuja Mukesh Phalak  Omkar Multispeciality Hospital  Survey No 94, Plot No 81, opposite to Yashada Windosong, Ravet, Pune, Pimpri-Chinchwad, Maharashtra 412101
Pune
MAHARASHTRA 		 9960789068
-
anujarnp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Care Multispeciality Hospital Institutional Ethics Committee   Approved 
Institutional Ethics Committee Sangvi Multispeciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A: Health supplement + Oral hypoglycemic agents (OHA).   Take 10 ml twice daily, one hour before lunch and dinner, with water for 90 days  
Comparator Agent  Group B: Placebo intervention + OHA  Take 10 ml twice daily, one hour before lunch and dinner, with water for 90 days 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male and female participants aged between 30 and 65 years (both inclusive)
2. Participants receiving oral hypoglycemic agents, biguanides, and sulfonylureas (Only combination)
3. Glycated hemoglobin (HbA1c) greater than 7% and less than 9 % ( both inclusive)
4. Participants willing to comply with the study procedure and sign the written informed consent
5. Participants with a BMI of less than 30 kg/m2 
 
ExclusionCriteria 
Details  1. Participant with Type 1 diabetes mellitus;
2. Participant taking antidiabetic drugs except for those specified in the inclusion criteria, including Insulin treatment;
3. Participants with concurrent serious hepatic dysfunction (defined as AST and/or ALT more than 3 times the upper normal limit) or renal dysfunction (defined as S. creatinine greater than 1.4 mg/dl), uncontrolled pulmonary dysfunction (asthmatic and COPD patients), or other concurrent severe disease
4. Participants suffering from major systemic illness necessitating long-term drug treatment including but not limited to hematologic conditions (e.g., hemolytic anemias, sickle cell anemia), acute myocardial infarction, unstable angina, uncontrolled hypertension, congestive heart failure (class III or class IV NYHA), or cerebrovascular accident, psychiatric or neurological disorder, autoimmune condition, received chronic (more than 14 days) therapy with systemic glucocorticoids (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) within six months prior to enrollment
5. Participants who are smokers/alcoholics and/or known drug abusers
6. Participants with evidence or history of malignancy
7. Participant enrolled in any other clinical trial requiring drug therapy
8. Pregnant or lactating women or women of fertile age not using effective contraception
9. Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Assessment of changes in HbA1c levels and Fasting and post-meal plasma glucose will be done
2. Assessment of changes in insulin resistance (HOMA-IR) will be assessed
 		 1.at screening and day 90 and baseline, day 30, day 60, and day 90.
2.at the baseline and day 90. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessment of change in lipid profile will be done
2. Assessment of changes in metabolic syndrome severity Z score (MetS Z score) will be assessed
3. Assessment of change in anthropometric parameters will be performed
4. Assessment of changes in serum C-reactive protein (CRP) levels will be assessed
5. Assessment of change in fatigue severity scale score (FSS) will be done
6. Assessment of change in diabetes related quality of life by DQOL will be done

 		 1.at baseline and day 90.
2.at baseline and day 90.
3.at screening, day 30, day 60, and day 90.
4. at the baseline and day 90
5. at baseline, day 30, day 60, and day 90.
6. at the baseline and day 90.
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   13/10/2025 
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="0"
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  

Type 2 Diabetes Mellitus is a chronic metabolic disorder characterized by insulin resistance, impaired insulin secretion, and elevated blood glucose levels. It presents a significant global health burden due to its associated complications, such as cardiovascular disease, nephropathy, neuropathy, and retinopathy. While pharmacologic and lifestyle interventions are standard, limitations related to side effects, cost, and adherence have driven interest in safe, adjunctive nutraceutical options.

Antox-D is a liquid nutraceutical formulation comprising FSSAI-approved botanical extracts including Momordica charantia (Karela), Syzygium cuminii (Jamun), Trigonella foenum-graecum (Methi), Withania somnifera (Ashwagandha), Aegle marmelos (Bael), and others. These components are supported by traditional use and emerging evidence for their antidiabetic, lipid-lowering, antioxidant, and anti-inflammatory properties. Potential benefits of Antox-D include reductions in fasting and postprandial glucose, HbA1c, reduced reliance on allopathic medication, and improved quality of life. However, these observations require validation through a well-designed clinical trial.

Pharmacologically, Antox-D’s ingredients exert complementary effects:

    Karela enhances insulin secretion and mimics insulin action.

  Jamun and Methi improve glycemic and lipid profiles.

    Bael offers nephroprotective and anti-glycation effects.

 Ashwagandha, Neem, and Triphala contribute neuroprotective, immunomodulatory, and detoxifying actions.

This study aims to evaluate the clinical efficacy and safety of Antox-D in T2DM individuals, assessing its impact on glycemic control, metabolic markers, and quality of life. Mechanistic insights from parallel in vitro studies will help rationalize observed outcomes and define its therapeutic potential.

Rationale for Dosing Interval – Investigational Product & OHA

Evidence suggests that certain phytoconstituent may modulate the pharmacokinetics and pharmacodynamics of oral hypoglycemic agents. Specifically, Gymnema sylvestre has been reported to reduce the bioavailability of metformin, whereas Momordica charantia (Karela) may potentiate its antihyperglycemic activity. Additionally, Azadirachta indica (Neem) and Zingiber officinale (Ginger) may antagonize the glucose-lowering effects of glibenclamide, while Trigonella foenum-graecum (Methi) and Syzygium cumini (Jamun) have been shown to prolong the action of gliclazide.

In light of these potential herb-drug interactions, the investigational product will be administered at least one hour prior to food intake to minimize the risk of altered glycemic control. As oral hypoglycemic agents (e.g., biguanides and sulfonylureas) are typically administered with or after meals, this dosing strategy ensures temporal separation, thereby reducing the likelihood of interaction-related hypoglycemic or hyperglycemic events. 
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