| CTRI Number |
CTRI/2025/03/082626 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| 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 THE EFFECT OF TRIKATVADI GUGGULU AND GOKSHURADI GUGGULU IN PATIENTS WITH TYPE 2 DIABETES MELLITUS ( PRAMEHA)
|
|
Scientific Title of Study
|
AN OPEN LABELLED RANDOMISED CONTROLLED CLINICAL
STUDY TO EVALUATE THE EFFECT OF TRIKATVADI GUGGULU IN PRAMEHA W.S.R. TO TYPE II DIABETES MELLITUS |
| Trial Acronym |
TRIKAT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit gera |
| Designation |
pg scholar |
| Affiliation |
SDM AYURVEDIC COLLEGE, HOSPITAL AND RESEARCH CENTER |
| Address |
DEPARTMENT OF KAYACHIKITSA
SDM AYURVEDIC COLLEGE, HOSPITAL AND RESEARCH CENTER, LAXMINAGAR, KUTHPADY, UDUPI
LAXMINAGAR, KUTHPADY, UDUPI
Udupi
KARNATAKA
574118
India |
| Phone |
8199909505 |
| Fax |
|
| Email |
rohitgera1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VEERAKUMARA K |
| Designation |
PROFESSOR |
| Affiliation |
SDM COLLEGE OF AYURVEDA |
| Address |
DEPARTMENT OF KAYACHIKITSA
SDM AYURVEDIC COLLEGE, HOSPITAL AND RESEARCH CENTER, LAXMINAGAR, KUTHPADY, UDUPI
Udupi
KARNATAKA
574118
India |
| Phone |
9743490753 |
| Fax |
|
| Email |
khadiravana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VEERAKUMARA K |
| Designation |
PROFESSOR |
| Affiliation |
SDM COLLEGE OF AYURVEDA |
| Address |
DEPARTMENT OF KAYACHIKITSA
SDM AYURVEDIC COLLEGE, HOSPITAL AND RESEARCH CENTER, LAXMINAGAR, KUTHPADY, UDUPI
Udupi
KARNATAKA
574118
India |
| Phone |
9743490753 |
| Fax |
|
| Email |
khadiravana@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM COLLEGE OF AYURVEDA, HOSPITAL AND RESEARCH CENTER, LAXMINAGAR, KUTHPADY, UDUPI, KARNATAKA, INDIA - 574118 |
|
|
Primary Sponsor
|
| Name |
SDM COLLEGE OF AYURVEDA, HOSPITAL AND RESEARCH CENTER |
| Address |
LAXMINAGAR, KUTHPADY, UDUPI, KARNATAKA |
| Type of Sponsor |
Private 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 ROHIT GERA |
SDM COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTER |
Department of Kayachikitsa OPD-7 Kayachikitsa, Udupi, KARNATAKA
Udupi
KARNATAKA |
8199909505
rohitgera1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SDM COLLEGE OF AYURVEDA UDUPI |
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: TRIKATVADI GUGGULU, Reference: VRINDA MADHAVA ATHVA SIDHA YOGA, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: GOKSHURADI GUGGULU, Reference: VRINDA MADHAVA ATHVA SIDHA YOGA, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the following criteria:
1. Fasting blood sugar level between 126mg/dl TO 250mg/dl
2. Post prandial blood sugar level between 200mg/dl to 300mg/dl
3.Subjects who are willing to sign the consent form to participate in the research |
|
| ExclusionCriteria |
| Details |
1. Diabetic complications.
2. Any life-threatening disorder interfering with the treatment.
3. Pregnant and lactating women
4. Had participated in any clinical trial within 3 months of screening. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fasting Blood Sugar Level
Post Prandial Blood Sugar Level |
14 AND 28 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Avila mootrata (Turbidity in urine)
Pipasaadhikya (Polydipsia)
Kshudaadhikya (polyphagia)
Dourbalya (debility)
Mukhatalushosha (dryness of oral cavity)
Kara padadaha (neuropathy)
Kara padasuptata (neuropathy)
Shithilangata (fatigue) |
14 AND 28 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/03/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
PRAMEHA: A COMPREHENSIVE ANALYSIS FROM VARIOUS
COMPENDIUMS - wjpr - Vol 13, Issue 20, 2024 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS IS A OPEN LABLE RANDOMISED CONTROLLED INTERVENTIONAL STUDY THAT WILL CHECK THE EFFICTIVENESS OF TRIKATVADI GUGGULU IN CONTROLLING DIABETES MELLITUS ALSO COMPARE IT TO STANDARD GOKSHURADI GUGGULU AND CHECK IT ON 14 AND 28 DAYS WITH PRIMARY OUTCOMES AS Fasting Blood Sugar Level AND Post Prandial Blood Sugar Level, WHERE AS SECONDARY OUTCOMES AS Avila mootrata (Turbidity in urine), Pipasaadhikya (Polydipsia), Kshudaadhikya (polyphagia), Dourbalya (debility), Mukhatalushosha (dryness of oral cavity), Kara padadaha (neuropathy), Kara padasuptata (neuropathy), Shithilangata (fatigue) |