| CTRI Number |
CTRI/2025/04/084399 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy Of Aamar Patra Aamra Pushpa And Aamra Twak In Prameha (Diabetes Milletus |
|
Scientific Title of Study
|
Comparative Study Of Aamra (Mangifera indica)i.e. Aamra Pallav, Aamra Pushpa And Aamra Twak In Prameha With Special Reference To 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 Swati Rammohan Tiwari |
| Designation |
Md (Ayu) Pg Scholar , Department Of Dravya Guna |
| Affiliation |
Maharashtra University Of Health Science , Nashik |
| Address |
11 Floor, Dravya Guna Department, K.G Mittal Ayurved College And Hospital , Netaji Subhash Road , Charni Road Mumbai
Mumbai
MAHARASHTRA
400002
India |
| Phone |
9869970800 |
| Fax |
|
| Email |
t.swati210@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Janhavi Rajesh Alwe |
| Designation |
Associate Professor |
| Affiliation |
Maharashtra University Of Health Science , Nashik |
| Address |
11th Fl, Dravya Guna Department, K.G Mittal Ayurved College And Hospital , Netaji Subhash Road , Charni Road Mumbai
11th Fl, Dravya Guna Department, K.G Mittal Ayurved College And Hospital , Netaji Subhash Road , Charni Road Mumbai
Mumbai
MAHARASHTRA
400002
India |
| Phone |
9324442463 |
| Fax |
|
| Email |
janhavialwe.JA@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Swati Rammohan Tiwari |
| Designation |
Pg Scholar , Department Of Dravya Guna |
| Affiliation |
Maharashtra University Of Health Science , Nashik |
| Address |
11th Fl, Dravya Guna Department, K.G Mittal Ayurved College And Hospital , Netaji Subhash Road , Charni Road Mumbai
11th Fl, Dravya Guna Department, K.G Mittal Ayurved College And Hospital , Netaji Subhash Road , Charni Road Mumbai
Mumbai
MAHARASHTRA
400002
India |
| Phone |
9869970800 |
| Fax |
|
| Email |
t.swati210@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.G Mittal Ayurved College And Hospital 11th Floor , Dravya Guna Department ,K.G.Mittal Ayurved College And Hospital , Netaji Subhash Road, Charni Road Mumbai 400002 |
|
|
Primary Sponsor
|
| Name |
K.G.Mittal Ayurved College And Hospital |
| Address |
K.G.Mittal Ayurved College And Hospital , Netaji Subhash Road , Charni Road , Mumbai 400002 |
| 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 |
| DrSwati Tiwari |
K. G Mittal Ayurved College And Hospital |
11th Floor, Dravya Guna Department, K.G.Mittal Ayurved College, And Hospital, Netaji Subhash Road , Mumbai 400002
Mumbai
MAHARASHTRA |
9869970800
t.swati210@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, K.G Mittal Ayurved College |
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: Aamra Pushpa, Reference: Adarsha Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Koshna jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aamra Twak , Reference: Adarsha Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Aamra Patra, Reference: Adarsh Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Blood sugar level
Fasting 125mg/dl to 250mg/dl
post Prandial 150mg/dl&350mg/dl
2.HbA1C 6.5 %&10% |
|
| ExclusionCriteria |
| Details |
1.Patient below 18YRS to Above 70 Yrs
2.Patient with type 1 diabetes Mellitus
3.Patient With Malignant Condition And Accelerated hypertension and Systematic Disease
4.Patient With Known Complication Of DM
5.Pregnant women and Lactating mother |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
efficacy of Aamra pallav(mangnifera indica linn)in reducing prameha /Diabetes Mellitus - parameter being blood sugar leval fasting and post prandial blood sugar level And hba1c
2.Efficacy of Aamra twak (mangnifera indica linn)in reducing prameha/ Diabetes Mellitus- parameter being blood sugar level (fasting and post prandial)and hba1c
3.Efficacy Aamra pushpa (Mangnifera indica linn.)in reducing prameha/Diabetes mellitus parameter being blood sugar level (fasting and post pradinal )and hba1c
4.Comparison between Aamra pallav , Aamra twak and Aamra pushpa churna in prameha |
FROM START AND AFTER 3 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Authentication and standardization-analytical study
1.Pharmacognosy -macroscopic and microscopic studies
2. Phytochemical study
3.Standardisation of drugs
Literature study of aamra
Comparative study of aamra different part (prayoga anga)
ADR (adverse drugs rection ) if noted in patient |
90 days |
Authentication and standardization-analytical study
1.Pharmacognosy -macroscopic and microscopic studies
2. Phytochemical study
3.Standardisation of drugs
Literature study of aamra
Comparative study of aamra different part (prayoga anga)
ADR (adverse drugs rection ) if noted in patient |
90 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/04/2025 |
| 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="0"
Months="3"
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
|
90 Patients presenting with symptoms of prameha will be selected by Randomized method (Alternate individual will be selected ). Selected individuals will be divided into three equal groups. Group will be divided into Group A , Group B and Group C with 30 individuals in each groups . Symptoms of prameha will be assessed by using blood sugar level ,Hba1c and urine glucose . Group A will be given Aamra patra churna 5 gram BD with koshna jala And Group B will be given Aamra twak churna 5gram BD with koshna jala And Group C will be given Aamra pushpa churna 5gram BD with koshna jala Pragbhakta for 3 month for 3 drugs .After intervention , the measurement parameter and symptoms of prameha of Group A, Group B And Group C individual will be reassessed by using the subjective and objective criteria
Generated data will be subjected to appropriate statistical test and conculsion will be drawn using statistical and observations found in study .
the pharmacognostical study , physical analysis , chemical analysis of three drugs will be studied during the trial |