| CTRI Number |
CTRI/2023/11/059441 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
24/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Gomutra haritaki on Diabetes mellitus type 2 |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Gomutra haritaki yog in the management of prameha(Madhumeha)W.S.R. Diabete mellitus type 2 |
| 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 Seeta Rajoria |
| Designation |
Associate professor & PhD Scholar |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College Udaipur |
| Address |
P.G. Dept. of Kayachikitsa Madan Mohan Malviya Govt. Ayurved
College Udaipur
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414605849 |
| Fax |
|
| Email |
sitarajoria29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brahmanand Sharma |
| Designation |
Associate Professor & guide |
| Affiliation |
Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur |
| Address |
P.G. Dept. of Kayachikitsa Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved
University,Jodhpur
P.G. Dept. of Kayachikitsa Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved
University,Jodhpur
Jodhpur
RAJASTHAN
324002
India |
| Phone |
7976964483 |
| Fax |
|
| Email |
bkmudgal9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brahmanand sharma |
| Designation |
Associate professor & guide |
| Affiliation |
Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur |
| Address |
P.G. Dept. of Kayachikitsa Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved
University, Jodhpur
P.G. Dept. of Kayachikitsa Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved
University, Jodhpur
Jodhpur
RAJASTHAN
324002
India |
| Phone |
7976964483 |
| Fax |
|
| Email |
bkmudgal9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Govt Ayurved College Udaipur |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Govt Ayurved College Udaipur |
| Address |
Madan Mohan Malviya Govt. Ayurved College, Radaji Circle
Ambamata, Udaipur 313001
|
| Type of Sponsor |
Government 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 |
| DrBrhmanand Sharma |
Madan Mohan Malviya Govt. Ayurved College Udaipur |
P.G. Dept. of
Kayachikitsa Madan
Mohan Malviya Govt.
Ayurved College
Udaipur Udaipur
RAJASTHAN
Udaipur
RAJASTHAN
Udaipur
RAJASTHAN |
7976964483
bkmudgal9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Sarvepalli Radhakrishnan Rujasthan Ayurved Uniersity, Jodhpur Post Graduate Institute of Ayurved 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: GomutraSadhitaHaritakiYoga, Reference: chakradat , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:yava,sarshapa tail,tikta kashaya pradhana dravyas for 90 days , Apathya:madhura,amla,lavana rasa pradhana dravyas
for 90 days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. The patients having clinical sign & symptoms of the Prameha (Madhumeh) & willing for
trial.
2. The patients who ages in between 25 – 70 years will be selected
3.international diagnosis criteria for diabetes (WHO)
(A) Patient having F.B.S. level >125 mg/dl <250 mg/dl (6.9 mmol/lit.)
(B) P.P.B.S. level >180 mg/dl to <350 mg/dl (10 mmol/lit.) will be selected for the trial
4. Either sex of different socio-economic groups. |
|
| ExclusionCriteria |
| Details |
1. IDDM patients
2. Gestational diabetes.
3. Diabetes Mellitus produced due to other illnesses like Acromegaly, Cushing’s syndrome,
pancreatic disorders etc.
4. Acute complications Diabetic Keto-acidosis & hyperglycemic hyperosmolar coma.
5. Pregnant & Lactating Mother.
6. History of severe unstable angina, MI, CVA, Renal failure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptoms like
Polyurea, Turbidity, burning sensation in palm and sole, polydipsia, fatigue, general weakness, polyphagia, sugar in the urine, and cramps will be analyzed
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| fasting blood sugar & post prandial blood sugar will be analyzed |
1 month & 2 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
10/11/2023 |
| 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 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 parallel group study to evaluate the efficacy of gomutra haritaki in the management of diabetes mellitus type 2.In this study,group A,50 patients will be administered with gomutra haritaki, 5 gm, od for the duration of 3 months.And group B,50 patients will be advised to follow pathya-apathya of prameha for 3 months |