| CTRI Number |
CTRI/2025/08/092716 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the Efficacy of Phalatrikadi Vasti and Phaltrikadi Kwath orally in one group with Standard Metformin Treatment in second group in Managing Type 2 Diabetes (Prameha) in age group 20-60 years. |
|
Scientific Title of Study
|
Evaluation of Comparative efficacy of Phalatrikadi Vasti followed by Phalatrikadi Kwath versus standard treatment (Tab Metformin) in the management of Diabetes Mellitus Type II (Prameha): A Randomized Controlled Trial |
| 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 Prasad Rukminikant Mirge |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Centre salod wardha, Maharashtra, India 442001 |
| Address |
OPD no 40 Department of Panchkarma Mahatma Gandhi Ayurveda College
Hospital and Research Centre Hirapur Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8087512586 |
| Fax |
|
| Email |
prasad99mirge@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Parwe |
| Designation |
HOD and Professor |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Centre wardha, |
| Address |
OPD no 40 Department of Panchkarma Mahatma Gandhi Ayurveda College
Hospital and Research Centre Hirapur Salod Wardha
Wardha
MAHARASHTRA
4420001
India |
| Phone |
9403142270 |
| Fax |
|
| Email |
shweta.parwe@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasad Rukminikant Mirge |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Centre |
| Address |
OPD no 40 Department of Panchkarma Mahatma Gandhi Ayurveda College
Hospital and Research Centre Hirapur Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8087512586 |
| Fax |
|
| Email |
prasad99mirge@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha, Maharashtra, India , 442001
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
OPD no 40 Department of Panchkarma Mahatma Gandhi Ayurved College Hospital
and Research Centre Hirapur Salod Wardha MAHARASHTRA 442001 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prasad Rukminikant Mirge |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
OPD no 40 Department
of Panchkarma Mahatma
Gandhi Ayurved College
Hospital and Research
Centre Salod Hirapur
Wardha
MAHARASHTRA |
8087512586
prasad99mirge@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Institutional Ethics Committee |
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 | Comparator Arm (Non Ayurveda) | | - | Tablet Metformin | Tablet Metformin 500 mg will be orally administered once a day before food for 48 days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak siddhisthana 3/69, Procedure details: Phalatrikadi Niruha Vasti and Tila Taila Anuvasana Vasti will be administered in the sequence of 3 days Niruha Vasti followed by 1 day Anuvasana Vasti for 16 days followed by Phalatrikadi Kwath 20 ml twice a day after food for 32 days)
(1) Medicine Name: Phalatrikadi Vasti, Reference: charaka chiktsasthana 6/40, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 960(ml), Frequency: od, Duration: 12 Days(2) Medicine Name: Phalatrikadi kwath, Reference: charaka chiktsasthana 6/40, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Duration: 32 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give written informed consent
Patient with either sex having age between 20 to 60 years
Patients recently diagnosed for uncomplicated NIDDM (less than 6 months) and having
1 Fasting blood sugar level 126 to 200 mg per dl
2 Post meal blood sugar level 140 to 300mg per dl
Patients with type-2 DM for 6 months but not taking any other anti-hypoglycemic drugs
Diabetic Patients suffering from controlled hypertension Systolic blood pressure not more than 140 mmHg or an average Diastolic Blood Pressure not more than 90 mmHg
Patient fit for Vasti Karma as per the Ayurvedic classics
Newly Diagnosed Diabetic patients who are not willing for Allopathic medications
|
|
| ExclusionCriteria |
| Details |
Patients suffering from IDDM (Insulin dependent diabetes mellitus) and patients with Type-2 Diabetes on insulin therapy
Patients suffering from Juvenile Diabetes or Gestational diabetes (2024 ICD-10-CM Diagnosis Code O24.4)
Impaired glucose tolerance (2024 ICD-10-CM Diagnosis Code R73.02)
DM with complications Retinopathy, Nephropathy, neuropathy, previous history of coma
Patients suffering from any current acute illness, uncontrolled hypertension
Pregnant and Lactating women
Anorectal Pathologies
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the efficacy of Phalatrikadi Vasti followed by Phalatrikadi Kwath and Tab Metformin over Blood sugar levels (Fasting and Post prandial), Urine Sugar level in Diabetes Mellitus Type II |
at baseline
16 day
48 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison and assessment of efficacy of Phalatrikadi Vasti followed by Phalatrikadi Kwath and Tab Metformin over Blood sugar levels (Fasting and Post prandial), Urine Sugar level in Diabetes Mellitus Type II |
at baseline
2 weeks 2 days
6 weeks 6 days |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
09/10/2025 |
| 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="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
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a Randomized open labelled Standard controlled equivalence clinical trial. It will include a 48 days treatment period and at Day follow up period baseline, 16th and 48th day. |