| CTRI Number |
CTRI/2024/10/075873 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| 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
|
To study the add on effect of Ayurvedic Decoction with Metformin-SR in the treatment of diabetes |
|
Scientific Title of Study
|
Clinical study of add on effect of Kutaj-asanadi kwath along with Metformin-SR in the management of Prameha(NIDDM) |
| 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 Shubhangi Raviraj Chate |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Department of Kayachikitsa, Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9145722234 |
| Fax |
|
| Email |
shubhangichate0304@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadanand V Deshpande |
| Designation |
HOD and Professor Kayachikitsa department |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Department of Kayachikitsa, Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9960071113 |
| Fax |
|
| Email |
drsvdeshpande61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadanand V Deshpande |
| Designation |
HOD and Professor Kayachikitsa department |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Department of Kayachikitsa, Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune
MAHARASHTRA
411011
India |
| Phone |
9960071113 |
| Fax |
|
| Email |
drsvdeshpande61@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital, Rasta peth, Pune |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya, Department of Kayachikitsa, 1st floor, 583/2, Rasta peth, Pune- 411011 |
| Type of Sponsor |
Private medical college |
|
|
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 Shubhangi Raviraj Chate |
Seth Tarachand Ramnath Ayurvedic Hospital Pune |
Tilak Ayurved Mahavidyalaya, Department of Kayachikitsa, OPD no. 5, Ground floor, Rasta peth, Pune-411011
Pune
MAHARASHTRA |
9145722234
shubhangichate0304@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, TAMV Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E11||Type 2 diabetes mellitus. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Metformin SR | Metformin is in a class of drugs called Biguanides which controls blood sugar levels.
Dose- 500mg orally twice a day for 3 months | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kutaj-asanadi kwath, Reference: Yogratnakar Prameha Chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: to be given along with Metformin-SR 500mg for 3months |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of prameha.
Blood sugar level between -
Fasting:126-160mg/dl
Post Prandial:160-250mg/dl
HbA1C:6.5-9% |
|
| ExclusionCriteria |
| Details |
Type 1 Diabetes mellitus
Patient on insulin or steroid treatment
Pregnant women and lactating mother
Patient with any other systemic disorder
|
|
|
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 |
Change in blood sugar level
Change in HbA1C value for glycemic control in diabetic patients |
with gap of every 15days for 3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Recurrence of burning sensation at Hand, foot & sole
Recurrence of thirst |
90days |
|
|
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)
|
11/11/2024 |
| 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 mellitus is a clinical syndrome characterized by hyperglycemia caused by an absolute or relative deficiency of insulin and insulin resistance, lack of insulin, whether absolute or relative and affects the metabolism of carbohydrates. Type 2 diabetes mellitus has become an global epidemic. Modern medicine despite of offering variety of effect to treatment options can have several adverse effects. Ayurvedic management of diabetes aim not only to achieve strict glycemic control but also to treat main route cause of disease. Many drug and formula have described for internal and external use in ayurvedic samhitas one of which is Kutaj-asanadi kwath. This synopsis is an attempt to study the add on effect of Kutaj-asanadi kwath in prameha and improve the personal and social lack of patient which contain Kutaj, asanad, triphala which helps to reduce symptoms of prameha. The prevalance of DM is 11.5% Subject to parameters for measurment 1. Prabhuta mutrata 2. Pipasa 3. Kara-pada-tala daha Overall assessment of the result will made by considering the collective effect on all the parameters and scoring criteria. |