| CTRI Number |
CTRI/2025/04/085987 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| 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 Rasayana Churna along with Metformin in Diabetes Mellitus II |
|
Scientific Title of Study
|
An Open Randomized Control Clinical Trial of Add on Effect of Rasayana
Churna along with Metformin in Diabetes Mellitus II |
| 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 Saif Amir Chidre |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department Of Kayachikitsa, Shri Annasaheb Dange Ayurved Medical College Post Graduate
and Research Center Ashta Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9834640122 |
| Fax |
|
| Email |
saifchidre453@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Vitthal Lokhande |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Sangli |
| Address |
3rd Floor Department Of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate
and Research Center Ashta Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8149556591 |
| Fax |
|
| Email |
yoshitpriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita Vitthal Lokhande |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Sangli |
| Address |
3rd Floor Department Of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate
and Research Center Ashta Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8149556591 |
| Fax |
|
| Email |
yoshitpriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta tal walwa dist sangli maharashtra 416301 India |
|
|
Primary Sponsor
|
| Name |
Dr Saif Amir Chidre |
| Address |
Department of Kayachikitsa OPD No 1 Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center
Ashta tal walwa dist sangli maharashtra 416301 |
| Type of Sponsor |
Other [self] |
|
|
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 Saif Amir Chidre |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
Department of Kayachikitsa OPDIPD Sangli
Sangli
MAHARASHTRA |
9834640122
saifchidre453@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research center Ethics Committee Ashta |
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: RASAYANA CHURNA, Reference: ASHTANG HRUDAY UTTAR STHANA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: MADHU), Additional Information: RASAYANA CHURNA ALONG WITH METFORMIN 500 MG BID | | 2 | Comparator Arm (Non Ayurveda) | Drug | Other than Classical | | (1) Medicine Name: METFORMIN, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | Drug | - | | |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients aged between 25-70 years with irrespective of gender, education, religion, socio economic class.
2) Patients presenting with classical features of Prameha, that is pipasavridhi (Polydyspsia) ,
Prabhuta- mutrata (Polyuria), Avila -mutrata
(Turbidity),Nakta-mutrata (Nocturia),Daurbalya(Fatigue).
3) Patients having sign and symptoms of Prameha
4) History of Diabetes Mellitus II Since 3 years and newly diagnosed cases.
5) Blood Sugar levels- Fasting more than 126 mg/dl PP more than 200 mg/dl
6) HbA1c more than 6.5% to 8%
|
|
| ExclusionCriteria |
| Details |
1) Patients with Insulin Dependent Diabetes Mellitus (DM I).
2) Patient with Diabetes mellitus II on Insulin therapy
3) History of Diabetes Mellitus-II more than 3 years
4) Patients aged less than 25 years and more than 70 years.
5) Patient presenting with Prameha due to the complication of other major systemic
diseases like Heart diseases ,Diabetic Macrovascular and Microvascular
complications, etc.
6) Pregnant women and lactating mothers will be excluded.
7) BSL- Fasting more than 250mg/dl ,PP more than 350mg/dl
8) HbA1c more than 8% |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rasayana Churna is effective along with Metformin in Diabetes Mellitus II |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease HbA1C Level & Symptomes after 60 Days |
60 Days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
12/05/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes Mellitus type II is a Metabolic disorder, characterized by impaired insulin secretion, insulin resistance, excessive hepatic glucose production, abnormal carbohydrate, protein and fat metabolism and systemic low-grade inflammation . This metabolic disorder results in long-term disease specific microangiopathy (nephropathy, retinopathy, neuropathy) and aggravation of macroangiopathy like Myocardial Infarction, Stroke. Diabetes can be correlated to Prameha in Ayurveda. Symptoms of Prameha like prabhut mutrata, avil mutrata, pipasaaadhikya can be correlated with polyuria, urine turbidity, polydipsia in Diabetes Mellitus type II. Now a days, due to Urbanization, sedentary life style, increased population and improper dietary habits the prevalence of Diabetes is increasing, also diabetes results in complications, and significant economic burden. There is need for effective, safe, potent, drug which controls hyperglycemia and adverse reaction and limit the signs symptoms related to Diabetes Mellitus type II and enhance patient quality of life. Hence, the present study will be done on the effects of Rasayana Churna Study Time-60 days Follow up - 0,15,30,45,60 Total duration of study -18 Months |