| CTRI Number |
CTRI/2026/04/108758 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
18/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [randomised comparative controlled ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see the effect of Chavydi ghana vati in kaphaj prameha ( Diabetes) |
|
Scientific Title of Study
|
Randomised controlled comparative clinical study to evaluate efficacy of Chavyadi ghana vati in sthul kaphaj prameha WSR to type two Diabetes mellitus |
| 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 Krutika Purushottam Ingle |
| Designation |
2nd year PG Scholar Kayachikitsa Dept. |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 |
| Address |
opd no 13 kayachikitsa aarogyashala rugnalaya Ayurved Seva Sangh Ayurved Mahavidyalay Nashik
ganeshwadi panchavati nashik 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
8805667635 |
| Fax |
|
| Email |
inglek310@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumudini Sukadev Sawale |
| Designation |
Proffesor Kayachikitsa Department |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 |
| Address |
Ayurved Seva Sangh Ayurved Mahavidyalay Ganeshwadi Panchavati Nashik
ganeshwadi panchavati nashik 422003
MAHARASHTRA
422003
India |
| Phone |
9923102717 |
| Fax |
|
| Email |
sawale.kumud@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krutika Purushottam Ingle |
| Designation |
2nd year PG Scholar Kayachikitsa Dept. |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 |
| Address |
opd no 13 kayachikitsa department aarogyashala department Ayurved Seva Sangh Ayurved Mahavidyalay Nashik
ganeshwadi panchavati nashik 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
8805667635 |
| Fax |
|
| Email |
inglek310@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved seva sangh ayurved mahavidyalaya ganeshwadi panchavati Nashik 422003 maharashtra india |
|
|
Primary Sponsor
|
| Name |
Dr Krutika Purushottam Ingle |
| Address |
Opd no 13 Aarogyashala Rugnalaya Ganeshwadi panchavati nashik 422003 |
| Type of Sponsor |
Other [Govt aided ayurvedic hospital] |
|
|
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 Krutika Purushottam Ingle |
Arogyashala Rugnalaya |
opd no 13 kayachikitsa department aarogyashala rugnalaya Ayurved Seva Sangh Ayurved Mahavidyalay Nashik
ganeshwadi panchavati nashik 422002
Nashik
MAHARASHTRA |
08805667635
inglek310@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Ayurved Seva Sangh Ayurved mahavidyalaya, Nashik |
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: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: nishaamalaki vati, Reference: charak samhita, Route: Oral, Dosage Form: Modaka , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chavyadi Ghan vati, Reference: bharatbhaishyajya ratnakar, Route: Oral, Dosage Form: Modaka , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having age group 30 to 70 years
Patients of any gender, religion & socio economic status
Patients having sign symptoms of prameha with BMI 25 to 30
HBa1c 6.5 to 8.5 %
|
|
| ExclusionCriteria |
| Details |
IDDM patients
Patients having HBa1c less than 6.5% and more than 8.5%
pregnancy ,unconscious patients
Juvenile diabetes,Acromegaly,cushings syndrome,pancreatic disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in HB A1c level
Reduction in symptoms of sthul kaphaj prameha |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in sthaulya
Reduction in kapha dominant features |
18 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/04/2026 |
| 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) |
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 group of metabolic diseases in which a person has high blood sugar either because the body does not produce enough insulin or because the cells do not respond to the insulin that is produced The high blood sugar level in diabetes produces classical symptoms of polyuria polydipsia and polyphagia Conventionally Diabetes has been divided into three types Type 1 IDDM TYPE 2 NIDDM Gestational Diabetes. Type 1 DM isInsulin Dependent Diabetes Mellitus in which body fails to produce insulin Also term as Juvenile Diabetes Type 2 DM is Non-Insulin Dependent Diabetes Mellitus results from insulin resistance a condition in which cells fails to use insulin properly with or without an absolute insulin deficiency term as adult onset of diabetes Gestational Diabetes occurs when a women without previous history of diabetes develop a high blood sugar level during their pregnancy It may precede Type 2 DM Ayurveda An ancient science which deals with life The aim of Ayurveda is not only to cure the diseases but also prevention of diseases Now a days due to changing lifestyle the incidence of life-threatning conditions is rising significantly World Health Organisations WHO enlisted various diseases including metabolic diseases and various systemic systemic diseases and disorders are causes of high mortality rate in india |