| CTRI Number |
CTRI/2024/07/071436 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Karvellak Churna and Pathya Ahara in Pre Diabetes |
|
Scientific Title of Study
|
Comparative study of effect of Karvellak Churna and Pathya Ahara in Pre Diabetes in relation to Meda Dhatu |
| 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 Shakuntala Nagar |
| Designation |
Assistant Professor |
| Affiliation |
Goverment Ayurved college Kota |
| Address |
Department of Kriya Sharir Room No. 14 Goverment Ayurved college Talwandi Kota rajasthan
Kota
RAJASTHAN
324005
India |
| Phone |
9785564108 |
| Fax |
|
| Email |
nagarshakuntala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Chandra Sharma |
| Designation |
Associate Professor |
| Affiliation |
DSRRAU JODHPUR |
| Address |
Department of Kriya Sharir Dr Sarveplli Radhakrishnan Rajasthan Ayurved University Kadvad Nagaur Road Jodhpur
Jodhpur
RAJASTHAN
342304
India |
| Phone |
9461691454 |
| Fax |
|
| Email |
dr_dcsharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Chandra Sharma |
| Designation |
Associate Professor |
| Affiliation |
DSRRAU JODHPUR |
| Address |
Department of Kriya Sharir Dr Sarveplli Radhakrishnan Rajasthan Ayurved University Kadvad Nagaur Road Jodhpur
Jodhpur
RAJASTHAN
342304
India |
| Phone |
9461691454 |
| Fax |
|
| Email |
dr_dcsharma@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved Hospital Talwandi Kota |
|
|
Primary Sponsor
|
| Name |
Dr Shakuntala Nagar |
| Address |
Government Ayurved Hospital Talwandi Kota Rajasthan Pincode 324005 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shakuntala Nagar |
Government Ayurved Hospital |
Room Number 14 Department of Kriya Sharir Talwandi Pincode 324005
Kota
RAJASTHAN |
9785564108
nagarshakuntala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Post Graduate Institute of Ayurved Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Yava as a diet(Daliya)200gm/day Duration 3 months , Apathya: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karvellak Churna, Reference: Kai. Nig.591, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Pathya Ahara |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical sign & symptoms of Prameha (prediabetes) according to Ayurveda and according to modern system of medicine. |
|
| ExclusionCriteria |
| Details |
Patients with long term medication for diabetes and cytotoxic treatment.
Patients are suffering from serious illness of any of system.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fasting blood sugar level 100 to 125 mg/dl
Postprandial blood sugar level 140 to 199 mg/dl
|
1month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Laboratory Investigation- Fasting blood sugar, Postprandial blood sugar, HbA1c test
|
3month |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/10/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Diabetes mellitus is measure health problem in 21 century in year 2000 India is one of the five countries which have highest sufferers of diabetes mellitus, hence India is declared is capital of diabetes now in spite of advanced medical researches it is still burning issue that 50% of diabetic patient are remaining undiagnosed. Changing diet habits, lifestyle change, unbalanced diet, excess fast food, lacks of exercise are the reasons behind development of growth of diabetes and its root is in urbanization Pre-diabetes is the precursor stage of Type-2 Diabetes Mellitus and often referred as ‘Grey area’ between diabetes and normal one. In recent years, the incidence of Prediabetes is rising with an alarming rate globally. It is also known as borderline diabetes, chemical diabetes & touch of diabetes. Obesity and insulin resistance are considered as it’s the main culprit and in due course of time it may lead to develop Type-2 Diabetes Mellitus. Large percentage of population affected with DM-2. In this situation, by subsidizing or cure this disease at the pre-diabetes level through Ayurvedic medication & life style changes so patients can be saved from future diabetic complications. Main aim of this study to evaluate the clinical efficacy of Karvellaka Churna in pre-diabetic patients.
|