| CTRI Number |
CTRI/2022/07/044000 [Registered on: 14/07/2022] Trial Registered Prospectively |
| Last Modified On: |
10/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Approach For Type-2 Diabetes Mellitus |
|
Scientific Title of Study
|
A Comparative Study Of Chandra Kala Gudika And Bougainvillea-Annona Patra Ghana Vati in Madhumeha (Type-2 Diabetes Mellitus) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Upadhyay |
| Designation |
P G Scholar |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurveda University |
| Address |
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurveda University Haridwar
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurveda University Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9917782541 |
| Fax |
|
| Email |
nehau0020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr OP Singh |
| Designation |
Professor |
| Affiliation |
Rishikul Campus Uttarakhand Ayurveda University Haridwar |
| Address |
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurveda University Haridwar
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurveda University Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411503035 |
| Fax |
|
| Email |
dr.opsingh63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr OP Singh |
| Designation |
Professor |
| Affiliation |
Rishikul Campus Uttarakhand Ayurveda University Haridwar |
| Address |
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurveda University Haridwar
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurveda University Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411503035 |
| Fax |
|
| Email |
dr.opsingh63@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Neha Upadhyay, P.G Department of Kayachikitsa Rishikul Campus Haridwar |
|
|
Primary Sponsor
|
| Name |
Dr Neha Upadhyay |
| Address |
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurveda University Haridwar
249401 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Neha Upadhyay |
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurveda University Haridwar
249401 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neha Upadhyay |
Rishikul Campus Uttarakhand Ayurveda University Haridwar |
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurveda University Haridwar
Hardwar
UTTARANCHAL |
9917782541
nehau0020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Uttarakhand Ayurveda University |
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: TYPE2 DIABETES MELLITUS, (2) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: Madhumeha, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Bougainvillea Annona Patra Ghana Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Luke Warm Water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chandra Kala Gudika, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Fasting blood glucose level>110mg/dl<250mg/dl.
2.Post prandial blood sugar level>140mg/dl<350mg/dl.
3.Patients between the age group of 30-60 years.
4.Chronicity-max. upto 5 years. |
|
| ExclusionCriteria |
| Details |
1.Patients of Type 1 Diabetes Mellitus.
2.Age below 30 years and above 60 years.
3.Blood sugar-fasting blood sugar level>250mg/dl.
4.Post Prandial blood sugar level>350mg/dl.
5.Patients having complications.
6.Patients suffering from any serious medical or surgical illness.
7.Chronic Diabetic patients (chronicity more than 5 years.). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of MADHUMEHA (TYPE2 DIABETES MELLITUS) are Prabhoot mutrata, Avil mutrata, Ati-kshudha, Pipasa-adhikya, Karpada-daha, Daurbalya. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in-
1.BloodSugar-Fasting
2.BloodSugar-Post-Prandial
3.HbA1c
4.Urine Sugar
5.BMI |
90 Days |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Madhumeha is one among 20 types of prime(urological disorder) described in various Ayurvedic classics. Excess use of guru,snigdha,amla,and lavana,navanna, asya-sukha,atinindra,avyaam obtaining from samshodhana therapy are the major cause of madhumeha. All these factors lead to imbalance of Dosha cause Mandyaagni formation of ama dosga which increase kleda and also lead to margaavran.Due to Chedana, Lekhana, Medohara, Mootral, Shothar, Balya, Pramehaghan properties of CHANDRA KALA GUDIKA AND BOUGAINVILLEA ANNONA PATRA have taken for the study. |