FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/09/057282 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 24/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Herbal medicine, Allopathic medicine and lifestyle modification on newly diagnosed diabetes. 
Scientific Title of Study   A Randomized, Open-Labelled, active controlled, prospective clinical study to evaluate the Anti-Diabetic activity of a Standardized Ayurvedic Herbal Formulation (CTE Capsule) as compared to Standard Oral Hypoglycemic Therapy (with Metformin and Vildagliptin) in Newly Diagnosed type-2 Diabetic Patients. 
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 Milind Nikumbh 
Designation  Pro-vice chancellor, MUHS,Nashik 
Affiliation  MUHS,Nashik 
Address  Maharashtra university of Health Sciences, Vani-Dindori road, Nashik.

Nashik
MAHARASHTRA
422004
India 
Phone  9890000503  
Fax  6659130  
Email  provc@muhs.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Milind Nikumbh 
Designation  Pro-vice chancellor, MUHS,Nashik 
Affiliation  MUHS,Nashik 
Address  Maharashtra university of Health Sciences, Vani-Dindori road, Nashik.

Nashik
MAHARASHTRA
422004
India 
Phone  9890000503  
Fax  6659130  
Email  provc@muhs.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Milind Nikumbh 
Designation  Pro-vice chancellor, MUHS,Nashik 
Affiliation  MUHS,Nashik 
Address  Maharashtra university of Health Sciences, Vani-Dindori road, Nashik.

Nashik
MAHARASHTRA
422004
India 
Phone  9890000503  
Fax  6659130  
Email  provc@muhs.ac.in  
 
Source of Monetary or Material Support  
Maharashtra university of health Sciences 
 
Primary Sponsor  
Name  Maharashtra University of health sciences Nashik  
Address  Vani Dindori road Nashik 422004 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Chellaram Diabetes InstitutePune  Pune , 411021 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shishir Pande  Arogyashala Rugnalaya  OPD NO. 9 Research OPD
Nashik
MAHARASHTRA 		 9420830818

shishir.nsk@gmail.com 
Dr A G Unnikrishnan  Chellaram Diabetes Institute  Room No.118, Clinical Research Department
Pune
MAHARASHTRA 		 9689287337

uagcdi@cdi.org.in 
Dr Shweta TelangChaudhari  SMBT Institute of Medical Sciences and Research Centre  Ground Floor, OPD No. 17, Clinical Research Department, SMBT Institute of Medical Sciences and Research Centre Dhamangaon, Igatpuri, Nashik
Nashik
MAHARASHTRA 		 08600300834

drshwetachaudhari85@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Chellaram Diabetes Institute, Institutional Ethics Committee  Approved 
Government Ayurveda College, Nanded  Approved 
Institutional Ethics Committee Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik   Not Applicable 
SMBT Institute of Medical Sciences and Research Centre  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. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: CTE Capsule, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 180 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: along with ayurveda dietary advice
2Comparator Arm (Non Ayurveda)-Tab Metformin 500 mg, Tab Gliptin 50 mg, Ayurveda Herbal Standardized FormulationBefore meals for 180 days along with Ayurveda Dietary Advice
3Comparator Arm (Non Ayurveda)-Tab Metformin 500 mg and Tab Gliptin 50 mgfor 180 days with water along with Ayurveda Dietary Advice
4Comparator Arm (Non Ayurveda)-Tab Metformin 500 mg and Tab Gliptin 50 mgwith water before meals For 180 days along with Standard Dietary Advice
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Newly diagnosed T2DM with any symptom of Polyuria, Polydipsia, Polyphagia,
Bodyache, Giddiness, Polyneuritis, Fatigue,
Matted hair / entangled hair,
Sweet taste in mouth,
Numbness of Hands & Legs,
Burning sensation of hands & legs,
Dryness of mouth,
Dryness of palate,
Dryness of throat,
Polydipsia,
Increased bodily wastes,
Stickiness/excessive excreta at body orifices,
Burning sensation of body,
Numbness of body parts,
Tingling sensation,
Urine afflicted with symptoms as in urinary diseases,
Foul smell of body,
Always feeling sleepy,
Always feeling drowsy,
2. HbA1c 6.5 to 8.5
3. BMI More than 23 Upto 40
4. Not taking any OHA
5. Subjects of either sex, 18-60 years
6. Subjects who agree to participate in the study and submit a written informed consent
form
 
 
ExclusionCriteria 
Details  1.Known Cases of type I DM
2. Patients of gestational diabetes
3. Any unstable Heart disease
4. Pregnant / Lactating women.
5. Alcoholics and/or drug abusers
6. Patients with evidence of malignancy
7. Patients suffering from major systemic illness necessitating long term drug treatment
(Rheumatoid arthritis, Psycho-Neuro, endocrinal disorders, etc.)
8. Patients who have completed participation in any other clinical trial during the past
one (01) month.
9. Any other condition which the Investigator thinks may jeopardize the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in HbA1c from baseline
 		 180 days
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Signs & Symptoms of DM & Prameha
2. Reduction in BSL, Serum Insulin from baseline.
3. Reduction in Lipid profile from baseline
4. Reduction in BMI & waist circumference from baseline
5. Reduction in Diabetes Symptoms Questionnaire (DSQ) score from base line
 		 180 days 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   15/09/2023 
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   Diabetes is a multi factorial disease with complex multi-organ-multi-target crosstalk in the body. Currently, the theoretical assumptions framing the diabetes management strategies are reductionist and largely focus on reducing hyperglycemia through targeted molecular drugs. While they effectively reduce hyperglycemia, they may not be adequate to address the multifactorial etiopathology, chronicity and systemic complications of diabetes. Therefore, a holistic and systemic approach is essential for its successful management.i Ayurveda has potential in tackling diabetes, through diet and lifestyle, pharmacotherapy, or an appropriate combination of both We hypothesize that an integrative diabetes management strategy, combining holistic principles of Ayurveda, the Indian system of medicine, can play a pivotal role in this context. A personalized treatment approach for patients with diabetes may be possible through Ayurveda. Acceptability and compliance may be better on account of the socio-cultural acceptance of Ayurveda. Synergistic approach of modern medicine and Ayurveda could lead to better outcomes for patients of diabetes as opposed to treatment with either of the two.
Integrative approach of medicinal management can give a better answer to prevent the comorbidities of diabetes as well as obesity. Ayurved has clinically classified the management of diabetes as Thin Diabetic and Obese diabetics. This is a very unique approach of Ayurved to treat diabetes differently in obese and thin individuals. Advanced studies also suggest the difference in the pathophysiology and management of Obese and thin diabetic..
Assessment will be done as follows :
Intervention: a) Group A: Standard OHA Regimen + Standard Dietary Advice 
b) Group B: Standard OHA Regimen + Ayurveda Dietary Advice
 c) Group C: Standardized Ayurveda Herbal Formulation (CTE Capsules) + Ayurveda Dietary Advice 
d) Group D: Standard OHA Regimen + Ayurveda Herbal Standardized Formulation (CTE Capsules) + Ayurveda Dietary Advice Assessment : at baseline, 30 days, 60 days, 90 days, 120 days, 150 days and at the end of 180 days.  Study will be conducted on total of 144 subjects for 180 days .The study will be Multicentric.
 
Close