| CTRI Number |
CTRI/2025/03/082205 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of kutajasanadi kashaya in management of Diabetes Madhumeha |
|
Scientific Title of Study
|
Clinical Evaluation of Kutajasandi Kashaya in The Management Of Madhumeha with special reference to Type 2 Diabetes Mellitus |
| Trial Acronym |
Diabetes |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sneha Gupta |
| Designation |
Junior Resident |
| Affiliation |
Department of Kaychikitsa Faculty Of Ayurveda IMS BHU |
| Address |
Department of Kaychikitsa Faculty Of Ayurveda IMS BHU Sir Sundar Lal Hospital IMS BHU Varanasi Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
07398749659 |
| Fax |
|
| Email |
drsnehaimsbhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meera Antiwal |
| Designation |
Assistant Prpfessor |
| Affiliation |
Department of Kaychikitsa Faculty Of Ayurveda IMS BHU |
| Address |
Department of Kaychikitsa Faculty Of Ayurveda IMS BHU Sir Sundar Lal Hospital IMS BHU Varanasi Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09451586325 |
| Fax |
|
| Email |
antiwalmeera@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meera Antiwal |
| Designation |
Assistant Prpfessor |
| Affiliation |
Department of Kaychikitsa Faculty Of Ayurveda IMS BHU |
| Address |
Department of Kaychikitsa Faculty Of Ayurveda IMS BHU Sir Sundar Lal Hospital IMS BHU Varanasi Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09451586325 |
| Fax |
|
| Email |
antiwalmeera@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Kayachikitsa Faculty Of Ayurveda Institute Of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 |
|
|
Primary Sponsor
|
| Name |
Dr Sneha Gupta |
| Address |
Department Of Kaychikitsa Faculty Of Ayurveda IMS BHU Varanasi 221005 |
| 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 Sneha Gupta |
Sir Sundar Lal Hospital Institute Of Medical Sciences BHU |
Kayachilitsa OPD 21 and 22 Sir Sundar Lal Hospital Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH |
7398749659
drsnehaimsbhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institue Of Medical Sciences Banaras Hindu University |
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: Kutajasanadi Kashaya , Reference: Vangsen Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -Not applicable | | 2 | Comparator Arm (Non Ayurveda) | | - | Metformin | Medicine name metformin route oral Dose 500 mg frequency OD after meal with water Duration 3 months |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Fasting blood glucose level more than 126 mg/dl upto 200 mg/dl more than two occasion on different days
Postprandial blood glucose more than 200 mg/dl upto 300 mg/dl
An HbA1c [Glycosylated Heamoglobin] level of 6.5 percent or more
Patients having classical symptoms of diabetes with
Random blood sugar more than 200mg/dl
|
|
| ExclusionCriteria |
| Details |
Known case of Type 1 Diabetes Melitus
Postprandial blood sugar more than 300 mg/dl
Diabetics of more than 3 yrs of duration
Patients having Diabetic Neuropathy Nephropathy Retinopathy related complications
|
|
|
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 |
Improvement in Prabhuta Mutrata (Polyuria)
Pipasaadhikya (Polydipsia)
Khudaadhikya (Polyphagia)
Daurbalya (Weakness)
Galatalu Shosh (Dryness in mouth)
Karpada Tala Daha (Burning sensation in palm and foot)
|
Evaluation will be done at every 15 days upto 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement In Fasting Postprandial and HbA1cl level |
Evaluation will be done at every 15 days upto 3 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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
70 cases of Madhumeha will be included in this interventional study which will be randomaly divided into 2 groups of 35 patients in each group one group will be prescribed Kutajasanadi Kashaya 40 ml BD and the other group will be prescribed Metformin 500 mg OD The study will be conducted fpr 90 days with follow up after every 15 days |