| CTRI Number |
CTRI/2025/08/092507 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of Chandraprava Vati on prodromal symptoms of Madhumeha
|
|
Scientific Title of Study
|
Evaluating the efficacy of Chandraprava Vati on purvarupa of Madhumeha(Prediabetes): An open label randomized clinical trial
|
| 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 Sanjib Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
Affiliated to NCISM, Govt of India |
| Address |
Sri Sri College of Ayurvedic Science and Research Hospital Department of Kayachikitsa
Sri Sri University,Iconic Building, 3rd Floor Room No.309,Bidyadharpur, Cuttack, Odisha
Cuttack
ORISSA
754006
India |
| Phone |
09437292457 |
| Fax |
|
| Email |
ayursanjib@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjib Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
Affiliated to NCISM, Govt of India |
| Address |
Sri Sri College of Ayurvedic Science and Research Hospital,
Department of Kayachikitsa
Sri Sri University,Iconic Building, 3rd Floor Room No.309,Bidyadharpur, Cuttack, Odisha
Cuttack
ORISSA
754006
India |
| Phone |
09437292457 |
| Fax |
|
| Email |
ayursanjib@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjib Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
Private |
| Address |
Sri Sri College of Ayurvedic Science and Research Hospital Department of Kayachikitsa
Sri Sri University,Iconic Building, 3rd Floor Room No.309,Bidyadharpur, Cuttack, Odisha
Cuttack
ORISSA
754006
India |
| Phone |
09437292457 |
| Fax |
|
| Email |
ayursanjib@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sanjib Kumar Das |
| Address |
Dr Sanjib Kumar Das,
Sri Sri College of Ayurvedic Science and Research Hospital Department of Kayachikitsa, Sri Sri University,Iconic Building, 3rd Floor Room No.309,Bidyadharpur, Cuttack, Odisha |
| Type of Sponsor |
Other [] |
|
|
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 Sanjib Kumar Das |
Sri Sri Ayurveda Hospital |
Sri Sri College of Ayurvedic Science and Research Hospital Department of Kayachikitsa Division- C Block Room No- C03 Odisha
Cuttack
ORISSA |
09437292457
ayursanjib@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical Research of Faculty of Health and Wellness Sri Sri College of Ayurvedic Science and Research Hospital Sri Sri University Cuttack 754006 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, (2) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chandraprava Vati , Reference: Vasava Rajeeyam Navamaprakaranam: Adhya - 9 Prameha, p-287 by Prof. (Dr) Gyanendra pandey Chowkhamba Krishnadas Academy, Varanasi – 201), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -HONEY), Additional Information: - | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: Wake up early (Brahma Muhurta
3o minutes brisk walking, Ritucarya: Not included, Acara Rasayana:Not Included, Other:, Pathya/Apathya:yes, Pathya:Fried yava yava sattu, old Sali – shsstika rice, Sidhu,Madhwika, Persons habitually taking roasted barley, dry corn, Millet, Oats, Apathya:Soubiraka, Tushodaka, Sukta, Sura, Asava, Ghrita, Dadhi, Ekshyu Vikara etc |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Fulfill prediabetes diagnostic criteria
HbA1c = 5.7-6.4%
Capable and willing of giving signed consent form
BMI (25-30) kg/m2
|
|
| ExclusionCriteria |
| Details |
Patients with H/o prior use of medication to treat diabetes or diagnosed with diabetes
Newly diagnosed patients
Currently using oral hypoglycemic agents
Decompensated cardiac, kidney, hepatic failure, endocrine disorder.
Patients having used any medication for DM or pre diabetes in last 1 month.
Pregnant and lactating females.
Who have participated in any other study within 1 month before this study
conditions where there is an altered relationship between A1C and glycemia, such as; some hemoglobin variants, pregnancy (second and third trimesters and the postpartum period), glucose-6-phosphate dehydrogenase deficiency, HIV, hemodialysis, recent blood loss or transfusion, or erythropoietin therapy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HbA1c should be less than 5.7% |
6 month of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of improvement in LFT, KFT, Lipid profile, CBC, HOMA-IR, HOMA-Beta,
Assessment of improvement in Pipasa, Karapada Daha/Suptata, Alasya), |
12 month of study |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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)
|
18/08/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Various studies conducted on prediabetic individuals for prevention of progression to diabetes which include pharmacology therapy, yoga, life style modification. However ADR of pharmacolgy therapy and hurdles in long term sustainability of other interventions are found to be hurdles. Hence there is need of safe and effective remedies for its prevention which Ayurveda can do. |