| CTRI Number |
CTRI/2022/09/045202 [Registered on: 05/09/2022] Trial Registered Prospectively |
| Last Modified On: |
31/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment for controlling blood sugar level in the patients with Type 2 Diabetes mellitus |
|
Scientific Title of Study
|
A Double Blind RCT Study on the- Role of
Virechanottara Jaya vati with Lodradi Kashaya
Anupana and Neelakanta rasa with Phalatrikadi
Kashaya Anupana in Madhumeha (T2DM) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narasareddy |
| Designation |
Postgraduate |
| Affiliation |
|
| Address |
Department of PG Studies in Kayachikitsa room no 1 Pandith Taranath Govt Ayurvedic Medical College and Hospital Dr Rajakumar road Bellary-583101
Bellary
KARNATAKA
583101
India |
| Phone |
9449003332 |
| Fax |
|
| Email |
narasareddy9923@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Fareeda Begum Shaikh |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of PG Studies in Kayachikitsa room no 1 Pandith Taranath Govt Ayurvedic Medical College and Hospital Dr Rajakumar road Bellary-583101
Bellary
KARNATAKA
580301
India |
| Phone |
9886478611 |
| Fax |
|
| Email |
dr.fareedabegumshaikh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Fareeda Begum Shaikh |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of PG Studies in Kayachikitsa room no 1 Pandith Taranath Govt Ayurvedic Medical College and Hospital Dr Rajakumar road Bellary-583101
Bellary
KARNATAKA
580301
India |
| Phone |
9886478611 |
| Fax |
|
| Email |
dr.fareedabegumshaikh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pg studies in kayachikitsa room no 1 pandith taranath govt ayurvedic medical college and hospital dr,rajakumar road bellary-583101 |
|
|
Primary Sponsor
|
| Name |
Taranath govt ayurvedic medical college and hospital bellary |
| Address |
Department of pg studies in kayachikitsa room no 1 pandith taranath govt ayurvedic medical college and hospital dr,rajakumar road bellary-583101 |
| 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 |
| Dr Narasareddy |
Taranath Govt Ayurvedic Medical College and Hospital |
Department of PG Studies in Kayachikitsa room no 1 Pandith Taranath Govt Ayurvedic Medical College and Hospital Dr Rajakumar road Bellary-583101
Bellary
KARNATAKA |
9449003332
narasareddy9923@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TGAMCIEC |
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: Jayavati, Reference: Rasatarangini, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Lodradi kashaya), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Neelaknta rasa, Reference: Rasendra Sara Sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Phalatrikadi kashaya), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting with clinical features of Madhumeha(T2DM) will be selected.
1]Subjects with FBS 126mg/dl to 200 mg/dl.
2]Subjects with PPBS 160mg/dl to 400mg/dl.
3]Subjects with HbA1c 6.5% to 10%.
4]Subjects of either sex between the age group of
30 to 60 years.
5]Subjects who are fit for virechana.
6]Subjects irrespective of history of COVID-19. |
|
| ExclusionCriteria |
| Details |
1]Subjects of Type I DM,
2]Diabetic patient in ICU, post surgery.
3]Pregnancy and Lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1]To decrease blood sugar level
2] Prevention of complication of t2dm
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1]To decrease blood sugar level
2]Prevention of complication of t2DM |
10 Week, 15 week |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
09/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/09/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 Asthamaharoga1 , and is a progressive Avaranajanya vyadhi2 leads to Dhatukshaya with nearest correlation to diabetes mellitus. Among the Ayurvedic texts, Acharya Charaka, Vagbhata and Madhavakara have brought the word Madhumeha into use while naming 20 subtypes of Prameha3 , whereas Sushruta has used the word Kshaudrameha. ‘Madhu’ and ‘Kshaudra’ are literally synonyms of each other. But at a different place, ‘Madhumeha’ to has been used and Sushruta has devoted one complete chapter to the treatment of Madhumeha. He has accepted Madhumeha to be the stage of complication of Prameha. Kaphavrutha and Pittavrutha madhumeha are Sadya4 . Diabetes is one of the most dangerous metabolic diseases of the modern world. It is a disease in which the level of glucose in the blood increases beyond normal levels. Almost 98% of diabetic population in India constitutes of Type-2 Diabetes Mellitus the prevalence of type 2 diabetes mellitus is 2.4% in rural population and 11.6% in urban population5 . India is projected as diabetes capital. In the present pandemic covid-19, steroids are used as treatment protocol this leads to Hyperglycaemia6 and also due to multiple organ failure leads to mankind to suffer with T2DM. In November 2020 a global analysis published in the general diabetes, obesity and metabolism found that up to 14.4% people who are hospitalised with severe covid-19, Also developed diabetes7 . The oral hypoglycaemic drugs which are present they are not up to the mark to control the hyperglycaemic levels..Many complications make the patient to suffer throughout the life. A new breakthrough in conceptual understanding and applied preventive or curative modality is the need of the hour. Research question is whether Dhatwaagni correction, Shodhana, Avaranaghna, Amedo mutrala, Dhatu samyakara, Balya, Rasayana approach as a set of longitudinal regime is effective in Madhumeha patients who are already taking contemporary oral drugs. With an a alternate hypothesis to evaluate the effect of Virechana followed by Rasayana in patients of diabetes mellitus is intended with drug called Jayavati with Lodhradi kashaya Anupana and Neelakanta rasa with Phalatrikadi kashaya anupana. Hence the present study entitled “A DOUBLE BLIND RCT STUDY ON THEROLE OF VIRECHANOTTARA JAYA VATI WITH LODHRADI KASHAYA ANUPANA AND NEELAKANTA RASA WITH PHALATRIKADI KASHAYA ANUPANA IN MADHUMEHA (T2DM) "Is undertaken. |