| CTRI Number |
CTRI/2025/01/079194 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| 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
|
Role of Kampillakadi Yoga and Tab Metformin in Diabetes Mellitus Type 2 vis-a-vis Prameha |
|
Scientific Title of Study
|
A comparative clinical evaluation of kampillakadi yoga and metformin in the patients of type 2 diabetes Mellitus vis a vis madhumeha |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrKale Samruddhi Prakash |
| Designation |
MD(Ayu)Scholar |
| Affiliation |
Banaras hindu university |
| Address |
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9011948701 |
| Fax |
|
| Email |
samruddhikale1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAjai Kumar Pandey |
| Designation |
Associate professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9452827885 |
| Fax |
|
| Email |
drajaipandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAjai Kumar Pandey |
| Designation |
Associate professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9452827885 |
| Fax |
|
| Email |
drajaipandey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India 221005 |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa Faculty of ayurveda |
| Address |
Institute of Medical sciences Banaras Hindu University varanasi Uttar Pradesh India
221005 |
| Type of Sponsor |
Research institution and 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 |
| DrKale Samruddhi Prakash |
Sir Sundarlal Hospital |
Room no.21-22 kayachikitsa opd Indian medicinal wing BHU Varanasi Uttarpradesh
Varanasi
UTTAR PRADESH |
9011948701
samruddhikale1996@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHU,IMS,institutional ethics committee |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kampillakadi yoga , Reference: Charak samhita chikitsa sthana chapter no 6 prameha chikitsa shloka no 35 36 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Plain water), Additional Information: Each tablet of 500 mg 2 tablet thrice a day | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Metformin | 500 mg tablet ,twice in a day after meal |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 30 to 60 years
Newly diagnosed patient and patient having chronicity less than 3years.
Patient Body weight- normal to obese. (BMI18.5 to 34.9)
Patient having no family history of DM
Patient having Fasting blood sugar 126 mg/dl to 200 mg/dl
Patient having Post prandial blood sugar more than 200mg/dl to 300mg/dl
Patient having HbA1c more than 6.5% to 10%
Patient fulfilling the diagnostic criteria of American Diabetes Association and as mentioned In Ayurvedic text.
|
|
| ExclusionCriteria |
| Details |
Age less than 30 to more than 60 years
Patients having chronicity more than 3years
Moderately to grossly obese patients (BMI more than 35)
Type 1 diabetes.
Patient having Fasting blood sugar more than 200mg/dl
Patient having Post prandial blood sugar more than 300mg/dl
Patient having HbA1c more than 10%
Patients on medications other than Metformin
Patients on insulin therapy
Severe heart liver lung kidney disease or incurable Cancer with complication of diabetes mellitus discussed earlier.
|
|
|
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 |
polyuria
turbid urine
polydepsia
polyphagia
burning sensation in hand and feet
perspiration
dryness of palate and throat
feeling sweetness in mouth
Numbness
Fatiguibility
|
90 days with follow up interval at 30 days interval. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1Quality of life QOL-BREF
2Assessement of severity of agni
3assessment into 0-3 scale on the basis of severity and duration of DM.
4hematological investigations
(FBS PPBS HbA1c CRP Lipid profile RFT LFT) |
FBS and PPBS at every follow up of 30 days and other hematological tests at day 0 and day 90 . |
|
|
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)
|
10/02/2025 |
| 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) |
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
|
Aim
To clinically evaluate the Antidiabetic effect of Kampillakadi Yoga in the patients of Type 2 Diabetes Milletus vis-Ã -vis Madhumeha.
Objectives To assess the trial response of Kampillakadi Yoga on subjective and
objective parameters in patients of Madhumeha. To assess the trial response of Metformin
on subjective and objective parameters in patients of Madhumeha. To compare the safety and efficacy of the trial
drug with parallel control group i.e. Metformin
To assess & compare the dimensions of Quality-of-life
before and after treatment in both the parallel trial groups.
Plan of study
A total 70 patient having
clinical features of Type2DM will be selected from OPD and IPD of Kayachikitsa, S. S. Hospital, IMS,
B.H.U, Varanasi after thorough history taking, clinical and laboratory
examination. Patients of different age groups of either sex &
socio-economic status will be selected, on the basis of inclusion and exclusion
criteria. Most of the patients come to this hospital directly, while some of
them are referred cases from other medical centers or from local doctors.These selected patients will be recruited in to following two groups .
GROUP A (Ayurvedic intervention) Treated with Ayurvedic
formulation i.e. Kapillakadi yoga- 2 vati (of 500 mg each tablet) TDS
with plane water after meal.
GROUP B (Control group), Treated with modern drug i.e. Metformin- 500mg BD after meal. Duration of treatment
3 months with Follow ups at
1month interval.
|