| CTRI Number |
CTRI/2023/02/049654 [Registered on: 13/02/2023] Trial Registered Prospectively |
| Last Modified On: |
28/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To access the effacay of Vidangadi
Kwath and Chandraprabha Vati on Blood Glucose Level in Madhumeha
Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Randomized controlled study to compare the efficacy of Vidangadi
Kwath and Chandraprabha Vati on Blood Glucose Level 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 |
Pooja Kumari |
| Designation |
MD Scholar (Department of Kayachikitsa) |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi
South West
DELHI
110073
India |
| Phone |
9716999803 |
| Fax |
|
| Email |
poojakumar300594@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr N R SINGH |
| Designation |
Head Of Depatment |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no. 154 Academic Block Dept. of Kayachikitsa Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi
South West
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Kumari |
| Designation |
MD Scholar (Department of Kayachikitsa) |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi
South West
DELHI
110073
India |
| Phone |
9716999803 |
| Fax |
|
| Email |
poojakumar300594@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch Brahm Prakash Ayurved Charak Sansthan |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi |
| 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 |
| Pooja Kumari |
Ch Brahm Prakash Ayurved Charak Sansthan |
Room No. 146 Academic Block Dept. of Kayachikitsa Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi
South West
DELHI |
9716999803
poojakumar300594@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CBPACS |
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: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chandraprabha Vati, Reference: Sharangdhara Samhita Madhyam khand Adhyaya 7; 40-44, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidangadi Kwath, Reference: Yogratnakar utrardh samanya prameha chikistsa prakaran adhyaya 39 shlok 1, page no 85, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Fasting blood sugar-126-200mg/dl
2. Post- Prandial blood sugar-200-350mg/dl
3. Diagnosed case of Type2 Diabetes Mellitus since 6months.
4. Patients not dependent on Insulin.
5. Patients willing to sign the informed consent.
6. Patients who are able to take medicines orally. |
|
| ExclusionCriteria |
| Details |
1. Fasting blood sugar level<126mg/dl and >200 mg /dl.
2. Post- Prandial blood sugar level <200 mg/dl and >350 mg/dl.
3. Patients depending on the insulin for blood glucose control.
4. Patients with diabetic complications and co morbidity.
5. Patients suffering from secondary diabetes.
6.Pregnant ladies and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of Fasting and Post Prandial Blood Sugar Levels in Madhumehi subject Type2 Diabetes Mellitus |
Day 0, Day 1, Day15, Day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Following Clinical Feature
Polyuria
Turbid urine
Glycosuria
Increased sleep
Increase appetite
Excessive seating
Weakness
Excessive thirts |
Day 0, Day1, Day 15, Day 45 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2023 |
| Date of Study Completion (India) |
28/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Madhumeha is a clinical entity described in Ayurveda as one of the type of Vataj Prameha. Due to vitiated Vata patient passes excessive urine which is astringent, sweet, dry, slightly turbid, pale in colour and person eliminates urine resembling honey in taste and colour. Madhumeha is two distinct type, one due to Dhatukshaya and other due to Kapha-meda Avarana of vata dosh. In Margavaranjanya Madhumeha, the obstructed Vata is vitiated again and carries Ojas to basti thus manifests Madhumeha Diabetes Mellitus is a metabolic disorder of multiple etiologies characterized by chronic hyperglycemia with disturbances of carbohydrate, fat and protien metabolism resulting from defects in insulin scretion, insulin action or both. This leads into increased concentrations of glucose in the blood, which in turn damage many of the body’s systems.
This study is to compare the efficacy of Vidangadi kwath and Chandraprabha vati in managemet of Madhumeha(Type 2 Diabetes mellitus)
Total no of patients 50, 25 in each group, in group A Vidangadi Kwath is given in dose of 40 ml twice a day, Half an hour before meal. In group B Chandraprabha vati in dose of 500mg twice a day, Half an hour before meal . Study design is Single centered, Open lebel, Randomized, Interventional type, Comparative study. |