| CTRI Number |
CTRI/2024/11/076594 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EVALUATING THE EFFECT OF TRIPHALA BHAVITA YAVA SAKTU AND TRIPHALA BHAVITA SYAMAK SAKTU ALONG WITH DIET REGIMEN ( PATHYA AHARA) IN THE MANAGEMENT OF TYPE II DIABETES MELLITUS |
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Scientific Title of Study
|
A COMPARATIVE STUDY TO EVALUATE THE EFFICACY OF TRIPHALA BHAVITA YAVA SAKTU AND TRIPHALA BHAVITA SYAMAK SAKTU ALONG WITH DIET REGIMN PATHYA AHARA IN THE MANAGEMENT OF DIABETES MELLITUS - A RANDOMIZED CONTROL OPEN LABEL CLINICAL TRIAL
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| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravi kumar |
| Designation |
Pg Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No-622,Department of Swasthavrtta,Academic Block,Block-c,All India Institute of Ayurveda, New Delhi-110076
South
DELHI
110076
India |
| Phone |
9631941347 |
| Fax |
|
| Email |
Ravikk1005@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Shiv Kumar Harti |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No-622,Department of Swasthavrtta,Academic Block,Block-c,All India Institute of Ayurveda, New Delhi-110076
South
DELHI
110076
India |
| Phone |
9611275434 |
| Fax |
|
| Email |
shivakumarsharti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Medha Kulkarni |
| Designation |
Professor and HOD |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No-622,Department of Swasthavrtta,Academic Block,Block-c,All India Institute of Ayurveda, New Delhi-110076
South
DELHI
110076
India |
| Phone |
9890355305 |
| Fax |
|
| Email |
medha63@rediffmail.com |
|
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Source of Monetary or Material Support
|
| All India Institute of Ayurveda,Gautampuri,Sarita Vihar, New delhi-110076 |
|
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Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Mathura Road Gautampuri Sarita Vihar New Delhi,110076 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ravi kumar |
All India Institute of Ayurveda New Delhi |
Room no-622 department of swasthavritta all india institute of ayurveda gautampuri sarita vihar -110076
South
DELHI |
9631941347
Ravikk1005@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DIVISION OF TRANSLATIONAL RESEARCH & BIOSTATISTICS,INSTITUTIONAL ETHICS COMMITTEE,AIIA, NEW DELHI |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E11||Type 2 diabetes mellitus. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala Bhavita yava saktu, Reference: Bhavprakas, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Normal water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala Bhavita Syamak Saktu, Reference: Charak, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Normal Water), Additional Information: - |
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Inclusion Criteria
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| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with age group 35-60 years, suffering from Diabetes Mellitus type II.
2. Newly diagnosed case of DM type 2 with FBS 126mg/dl – 220mg/dl and PPS
180mg/dl – 280mg/dl and HbA1c range between 6.5% - 7.5%
3. Patient willing to participate in the study.
|
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| ExclusionCriteria |
| Details |
1. Patient suffering from Type 1 Diabetes Mellitus and other complications of diabetes such as diabetic neuropathy, Diabetic Retinopathy, Ischemic heart disease.
2. Patient with cardiovascular disease and other systemic Illness.
3. Pregnant women and lactating mother.
4. Patients not willing to participate in the Study
|
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Significant improvement in Symptoms of Madhumeha |
90 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Hba1c,FBS,PPBS |
90 Days |
|
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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" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="0"
Months="3"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
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The study will be carried out to evaluate the the role of Triphala Bhavita syamak saktu in management of Diabetes mellitus. Patients fullfilling the inclusion criteria will be divided into two groups. In control group Triphala
Bhavita yava saktu will be given in the dose of 10gm BD with Normal
water and in intervention group Triphala
Bhavita syamak saktu will be given in the dose of 10gm BD with
Normal water along with
holistic approach of Ayurveda (It contains Ayurveda Aushadh, Aahar, Vihar,
Yoga) for 3 months .After 3 months of intervention it will be expected that there will be reduction in HbA1c level, improvement in sign and symptoms of Madhumeha,, reduction in FBS,PPBS,RBS, Improvement in Quality of life in T2DM patients.
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