| CTRI Number |
CTRI/2024/05/066621 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study effects of Rasapachaka Kashaya on overweight Prediabetic persons. |
|
Scientific Title of Study
|
An open labeled randomized clinical trial to assess the efficacy of Rasapachaka Kashaya on overweight Prediabetic persons w.s.r. to Sthaulya. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snehal Sukhadeo Bhele |
| Designation |
PhD Scholar, Dept. of Kayachikitsa |
| Affiliation |
Govt. Ayurved College, Nanded |
| Address |
Department of Kayachikitsa, Ground floor, Government Ayurveda College, Vazirabad, Nanded.
Nanded
MAHARASHTRA
431601
India |
| Phone |
9420221403 |
| Fax |
|
| Email |
snehalbhele.sb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V E Gogate |
| Designation |
Asso. Professor, Det. of Kayachikitsa |
| Affiliation |
Govt. Ayurved College, Nanded |
| Address |
Department of Kayachikitsa, Ground Floor, Government Ayurved College, Vazirabad, Nanded.
Nanded
MAHARASHTRA
431601
India |
| Phone |
9422214311 |
| Fax |
|
| Email |
vgogate21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V E Gogate |
| Designation |
Asso. Professor, Det. of Kayachikitsa |
| Affiliation |
Govt. Ayurved College, Nanded |
| Address |
Department of Kayachikitsa, Ground Floor, Government Ayurved College, Vazirabad, Nanded.
Nanded
MAHARASHTRA
431601
India |
| Phone |
9422214311 |
| Fax |
|
| Email |
vgogate21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College, Nanded |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital Nanded |
| Address |
Government Ayurvedic College and Hospital, Vazirabad,Nanded, Maharashtra, 431601 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Snehal Sukhadeo Bhele |
PhD Scholar, Dept. of Kayachikitsa, Govt. Ayurvedic College and Hospital, Nanded |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Snehal Sukhadeo Bhele |
Government Ayurved College and Hospital, Nanded |
Room No.18, Department of Kayachikitsa
Nanded
MAHARASHTRA |
9420221403
snehalbhele.sb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Ayurved College Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasapachaka Kashaya, Reference: Kalingakadi yoga. Vishama Jwara chikitsa. Charaka Chikitsta Adyaya 3/200, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rukshaniya Dravya Churna , Reference: -, Route: Oral, Dosage Form: Churna/ Powder, Dose: 9(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with FPG:100-125mg/dL and HbA1c: 5.7-6.4% without any medication.
2. Age group 30-60 yrs.
3. Patients will be selected irrespective of their sex, religion, geographical areas and economical condition. |
|
| ExclusionCriteria |
| Details |
1. Patients with history of other diseases leading to DM (Autoimmune, Secondary to other diseases or condition).
2.Pregnant and lactating women.
3.Other major systemic disorders with complication.
4. Patients on steroidal intake for any other major systemic diseases. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the insulin resistance (HOMA-IR) value to be calculated with fasting glucose(mg/dl) ,fasting insulin levels(mu/L) and the HbA1c(%) values. |
0 and 91st days for objective criterias. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess effect of Rasapachaka Kashaya on Fasting Plasma Glucose, HbA1c.
2. To assess the effect of Rasapachaka Kashaya on Insulin Resistance (Calculated with HOMA IR)
3. To study role of Rasapachaka Kashaya on Daurbalya, Atikshudha, Atitrushna.
4. To asses side effects of drug if any.
5. To assess the effect of Rasapachaka Kashaya in comparison with Rukshaniya Dravya Churna (3gm each with Koshna Jala) |
Fasting Plasma Glucose, HbA1c, Insulin Resistance (HOMA IR) on 0 and 91st days.
Daurbalya, Atikshudha, Atitrushna on 0, 30, 60, 91st days and follow up assessment on 150 days. |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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)
|
15/05/2024 |
| 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="2"
Months="0"
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 an open labeled randomized clinical trial on overweight prediabetic persons. The prevalence of Diabetes Mellitus and its harbinger, Impaired Glucose Tolerance (Prediabetes) is highest in India and United States. The disease is associated with early and ongoing secondary pathophysiologic changes contributing to conditions like Cardiovascular Disease. It is also associated with complications like End Stage Renal Disease, Non traumatic lower extrimity amputation, Adult blindness etc.Ayurveda provides holistic approach in diagnosing and treating diseases. Previous study was conducted on combination of Rukshan Dravya Churna (Triphala, Musta, Chitraka) which showed results on Insulin Resistance in Obese students. Rasapachaka Kashaya is mentioned for treatment of Visham Jwara in Charaka Chikitsa. It contains Indrayava, Patol and Kutaki and thus exhibit actions like Agnideepan, Amapachana, Strotoshodhana, Mala-apahar, Rechana and Bhedan according to Ayurveda. So they are advised for treating diseases like Jwara, Ama, Hridroga, Prameha etc. Thus, Rasapachaka Kashaya can counteract the pathology of the disease and re- establish proper metabolism in overweight Prediabetic persons. So the drug has been chosen as trail drug in the dose of 40 ml bid and Rukshaniya Dravya Churna as control drug in the dose of 9 g with leukwarm water for a period of 90 days in overweight prediabetic persons. |