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CTRI Number  CTRI/2024/06/068301 [Registered on: 04/06/2024] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   The combination of Berberis aristata and Phyllanthus emblica extract in the management of prediabetes.  
Scientific Title of Study   A Randomized, placebo-controlled study to assess the efficacy & safety of the combination of Berberis aristata and Phyllanthus emblica extract supplementation in prediabetic subjects. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/23-24/038 Version 1.00; dated 30 Jan 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohan Magdum 
Designation  Principal Investigator 
Affiliation  MJM Hospital 
Address  MJM Hospital Room no 102 Ghole road Sud nagar Shivajinagar

Pune
MAHARASHTRA
411005
India 
Phone  9822217243  
Fax  -  
Email  mohanmagdum@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Siddharth J Modi 
Designation  Assistant Manager, Clinical Research & Intellectual Property Rights 
Affiliation  Pharmanza Herbal Pvt. Ltd. 
Address  214 Borsad Tarapur Road Nr Vadadla Patiya Kaniya

Anand
GUJARAT
388430
India 
Phone  8487941016  
Fax  -  
Email  rdbiotech@pharmanza.com  
 
Details of Contact Person
Public Query  
Name  Dr Siddharth J Modi 
Designation  Assistant Manager, Clinical Research & Intellectual Property Rights 
Affiliation  Pharmanza Herbal Pvt. Ltd. 
Address  214 Borsad Tarapur Road Nr Vadadla Patiya Kaniya

Anand
GUJARAT
388430
India 
Phone  8487941016  
Fax  -  
Email  rdbiotech@pharmanza.com  
 
Source of Monetary or Material Support  
Pharmanza Herbal Pvt. Ltd. Plot # 214, Borsad-Tarapur Road,Nr. Vadadla Patiya, At & PO: Kaniya Ta: Petlad, Dist: Anand (Gujarat) India -388430. 
 
Primary Sponsor  
Name  Pharmanza Herbal Pvt. Ltd 
Address  Plot 214, Borsad-Tarapur Road,Nr. Vadadla Patiya, At & PO:KaniyaTa: Petlad, Dist: Anand (Gujarat) India 388430. 
Type of Sponsor  Other [Ayurvedic Industry] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Ramshyam Agarwal  Lokmanya Medical Research Centre and Hospital  4th-floor OPD 401-314 B Telco Road Chinchwad
Pune
MAHARASHTRA 		 8087282022
-
ramshyam.research@gmail.com 
Dr Mohan Magdum  MJM Hospital  1194 Janardan Sadan 1194 23 Ghole road Sud nagar Shivajinagar
Pune
MAHARASHTRA 		 9822217243
-
mohanmagdum@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R739||Hyperglycemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1: Berberis aristata extract and Phyllanthus emblica extract 500 mg capsule (NextBeriâ„¢).  Twice a day after breakfast and after dinner for 180 days. 
Intervention  Group 2: Berberis aristata extract and Phyllanthus emblica extract 250 mg capsule (NextBeriâ„¢).   Twice a day after breakfast and after dinner for 180 days 
Comparator Agent  Placebo 500 mg capsule.  Twice a day after breakfast and after dinner for 180 days. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Male and females aged 20 to 60 years (both inclusive); 2. Participants with BMI greater than or equal to 25.00 and less than or equal to 34.9 kg/meter square at screening (Overweight to obese class I); 3. Participants with Hemoglobin A1c (HbA1c) greater than or equal to 5.7 % and less than or equal to 6.4%; 4. Participants with Fasting Plasma Glucose (FPG) between 100-125 mg/dl (both inclusive), 2 hours glucose value between 140-199 mg/dl (both inclusive); 5. IDRS (Indian Diabetics Risk score) less than or equal to 60; 6. Participants providing voluntary, written informed consent to participate in the study. 
 
ExclusionCriteria 
Details  1. Participants with type 1 or type 2 diabetes mellitus gestational diabetes or secondary diabetes;
2. Participants with any other co-morbidity;
3. Participants treatment of a glucose-lowering or weight loss agent within 90 days before screening;
4. Participants with elevated liver enzymes AST and or ALT greater than 3 times of the upper normal limit;
5. Participants with abnormal renal function as measured by eGFR less than 45ml per min per 1.73 meter square;
6. Participants who had bariatric surgery;
7. Pregnant or lactating women;
8. Smokers alcoholics and or drug abusers;
9. Participants with a known history or ongoing malignancy;
10. Participants with the treatment of immunosuppressive medications in the past three months;
11. Participants suffering from major systemic illness necessitating medical care;
12. Any other reason that can affect the participation of the subject in the study as per investigators discretion. 
 
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. Changes in Glycemic profile by assessing
a) Oral Glucose Tolerance Test (OGTT), b) HbA1c, c) fasting and post-meal plasma glucose levels. 2. Changes in Insulin resistance by assessing a) Fasting insulin, b) HOMA-IR score. 3. Change in Fat metabolism by assessing Blood Lipid Profile. 4. Change in Oxidative stress markers by assessing a) Serum MDA levels, b) Serum SOD levels. 5. Change in Inflammatory markers by assessing a) TNF-alpha levels, b) CRP levels, c) IL-6 levels, d) SIRT 1 e) SIRT 6. 6. Change in Metabolism by assessing Metabolic Syndrome Severity Z Score. 7. Change in Anthropometric parameters by assessing Body weight, BMI and waist circumference. 8. Change in Quality of life by assessing HRQOL-15D questionnaire score. 		 1. a)At screening and Day 180, b)At screening and Day 180, c) On Day 45, Day 90 and Day 135. 2. a)At screening and Day 180, b)At screening and Day 180. 3. At screening, Day 90 and Day 180. 4. a)At screening and Day 180, b) At screening and Day 180. 5. a)At screening and Day 180, b) At screening and Day 180, c) At screening and Day 180, d)At screening and Day 180, e) At screening and Day 180. 6. At screening and Day 180. 7. At screening, Day 90 and Day 180. 8. At screening, Day 90 and Day 180. 
 
Secondary Outcome  
Outcome  TimePoints 
The safety of the intervention will be assessed by evaluating 1. Adverse events profile from baseline to end of the study 2. Tolerability and compliance of the investigational product from baseline to end of the study. 3. Changes in biochemical parameters like liver function test (LFT), renal function test (RFT), GFR and hematological profile at screening and end of the study 4. Changes in vital signs like blood pressure, heart rate etc throughout the study.  1. At baseline, Day 45, Day 90, Day 135, Day 180. 2. At baseline, Day 45, Day 90, Day 135, Day 180. 3. At Screening and Day 180. 4. At Screening, Baseline, Day 45, Day 90, Day 135, Day 180. 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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   N/A 
Date of First Enrollment (India)   10/06/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Standardized extracts of Berberis aristata and Phyllanthus emblica contain constituents that can regulate blood sugar levels and aid in the management of prediabetes. The purpose of this study is to evaluate the safety and effectiveness of Berberis aristata and Phyllanthus emblica extract capsules in prediabetic individuals. By combining the current research and clinical trials on the pharmacological benefits of micronutrients, it is possible to address the critical medical concern of the expanding prediabetic population by enhancing glycemic control, halting the progression of the disease, and potentially reversing the condition. This study employs a randomized, controlled clinical methodology to evaluate the efficacy and safety of nutritional supplementation in individuals at risk of developing diabetes. There will be daily telephonic follow-up of subjects for the absence of major lifestyle changes that would impact the study outcomes. The clinical validation of the investigational product compared to placebo will offer diabetologists and caregivers evidence and guidance for the therapeutic usage of standardized nutrients and phytoconstituents in the management of prediabetes. 


 
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