| CTRI Number |
CTRI/2025/04/083834 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study of effect of Madhutailik Basti(medicated enema) along with antidiabetic drugs in the treatment of type 2 diabetes mellitus(Prameha). |
|
Scientific Title of Study
|
A randomized control clinical study on the effect of Madhutailik Basti with oral hypoglycemic agents on HbA1c value in Prameha with special reference to type 2 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 Nilima Anandrao Patekar |
| Designation |
M.d. Scholar Panchakarma |
| Affiliation |
Sumatibhai shah Ayurveda Mahavidyalaya,Malwadi,Hadapsar,Pune |
| Address |
Sumatibhai shah Ayurveda Mahavidyalaya OPD No.6, Department of Panchakarma,Sane Guruji Arogya Kendra,Hadapsar,Malwadi,Pune 411028 Maharashtra India
Pune
MAHARASHTRA
411028
India |
| Phone |
9763014448 |
| Fax |
|
| Email |
classynilu118@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maya Gokhale |
| Designation |
Head of department of Panchakarma |
| Affiliation |
Sumatibhai shah Ayurveda Mahavidyalaya,Malwadi,Hadapsar,Pune |
| Address |
Sumatibhai shah Ayurveda Mahavidyalaya OPD No.6, Department of Panchakarma,Sane Guruji Arogya Kendra,Hadapsar,Malwadi,Pune 411028 Maharashtra India
Pune
MAHARASHTRA
411028
India |
| Phone |
9422323285 |
| Fax |
|
| Email |
drmayagokhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilima Anandrao Patekar |
| Designation |
M.d. scholar Panchakarma |
| Affiliation |
Sumatibhai shah Ayurveda Mahavidyalaya,Malwadi,Hadapsar,Pune |
| Address |
Sumatibhai shah Ayurveda Mahavidyalaya OPD No.6, Department of Panchakarma,Sane Guruji Arogya Kendra,Hadapsar,Malwadi,Pune 411028 Maharashtra India
Pune
MAHARASHTRA
411028
India |
| Phone |
9763014448 |
| Fax |
|
| Email |
classynilu118@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Sane Guruji Arogya kendra Malwadi Hadapsar Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Department of Panchakarma, Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 Maharashtra India |
| 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 |
| Dr Nilima Anandrao Patekar |
Sane Guruji Arogya kendra |
Sumatibhai shah Ayurveda Mahavidyalaya OPD No.6, Department of Panchakarma,Sane Guruji Arogya Kendra,Hadapsar,Malwadi,Pune 411028 Maharashtra India
Pune
MAHARASHTRA |
09763014448
classynilu118@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M.A.M.s SSAM and Sane Guruji Arogya Kendra Institutional ethical 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 | Procedure | - | mAdhutailikabastiH, माधुतैलिकबस्तिः Pradhan Karma | (Procedure Reference: Ashtang Hrudayam, Procedure details: Basti will be given for 7 days in consecutive 3 months along with regular OHA (oral hypoglycemic agents). 1st & 7th Basti of every month will be matra basti (Til tail) while Madhutailik Basti will be given in between (5 days).)
| | 2 | Comparator Arm (Non Ayurveda) | | - | oral hypoglycemic drugs | Monitoring of patients will be done who are taking only oral hypoglycemic agents upto 3 molecules as per their prescription. |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of Type 2 Diabetes Mellitus.
HbA1c value 6.5% or above. Age group between 30 to 60 years.
Patients taking anti-diabetic drugs.
Fasting blood sugar level within 150 mg/dl and Post prandial blood sugar
within 250 mg/dl. Patient who is taking regular OHA(Oral Hypoglycemic agents) upto three
molecules
Basti Arha18 |
|
| ExclusionCriteria |
| Details |
Patients of insulin dependent diabetes mellitus (Type I).
Diabetes due to Endocrinopathies for eg. Acromegaly, Cushing syndrome.
Drugs or chemical induced diabetes mellitus.
Hypertension
Patients with other systemic complication which may interfere in
treatment.
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of Madhutailik Basti with Oral hypoglycemic agents on
HbA1c value. |
Patients will be assessed on 0th, 7th, 37th, 67th day and follow up on 90th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effect of Madhutailik Basti with Oral hypoglycemic agents on
blood glucose level.
To study the effect of Madhutailik Basti with Oral hypoglycemic agents in
Prameha(Type 2 diabetes mellitus). |
Patients will be assessed on 0th, 7th, 37th, 67th day and follow up on 90th day.
Patients will be assessed on 0th, 7th, 37th, 67th day and follow up on 90th day. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/04/2025 |
| 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="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
|
This is a comparative clinical study of add on effect of Madhutailik Basti on HbA1c value in prameha (type 2 diabetes mellitus) with oral hypoglycemic agents. The primary objective is to study the effect of Madhutailik Basti with oral hypoglycemic agents on HbA1c value if given for 7 days in consecutive 3 months. one group of prameha (type 2 dibetes mellitus) patients will be treated with oral hypoglycemic agents. second group of prameha (type 2 diabetes mellitus) patients will be treated with Madhutailik Basti along with oral hypoglycemic agents to study the add on effect . |