| CTRI Number |
CTRI/2025/06/088739 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Clinical trial] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of efficacy of two ayurveda drugs namely Truptighna dadhemani tablet and Nisha Amalaki churna in the management of Type 2 Diabetes mellitus |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effectiveness of Truptighna dashemani and nisha amalaki churna in the management of prameha w.s.r. to type 2 diabetes mellitus |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nehaben Arvindbhai Chauhan |
| Designation |
PG scholar Kayachikitsa |
| Affiliation |
Shree swaminarayan ayurvedic college kalol |
| Address |
Department of Kayachikitsa, Shree swaminarayan ayurvedic college, opp GIDC,saij , Ahmedabad -Mehasana highway, AT&PO, Ta, saij, kalol , Gandhinagar
Department of kaya chikitsa,Shree Swaminarayan ayurvedic, opp GIDC,saij , Ahmedabad -Mehasana highway, AT&PO, Ta, saij, kalol -382725, Gandhinagar
Gandhinagar
GUJARAT
382725
India |
| Phone |
8401334056 |
| Fax |
|
| Email |
www.nehachauhantempo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Vd Tapan Kumar M |
| Designation |
Professor |
| Affiliation |
Shree swaminarayan ayurvedic college kalol |
| Address |
Department of Kayachikitsa, Shree swaminarayan ayurvedic college, opp GIDC,saij , Ahmedabad -Mehasana highway, AT&PO, Ta, saij, kalol , Gandhinagar
Department of kaya chikitsa,Shree Swaminarayan ayurvedic, opp GIDC,saij , Ahmedabad -Mehasana highway, AT&PO, Ta, saij, kalol -382725, Gandhinagar
Gandhinagar
GUJARAT
382725
India |
| Phone |
9924304388 |
| Fax |
|
| Email |
vdtapankumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishal Solanki |
| Designation |
Associate professor |
| Affiliation |
Shree swaminarayan ayurvedic college kalol |
| Address |
Department of Kayachikitsa, Shree swaminarayan ayurvedic college, opp GIDC,saij , Ahmedabad -Mehasana highway, AT&PO, Ta, saij, kalol , Gandhinagar
Department of kaya chikitsa,Shree Swaminarayan ayurvedic, opp GIDC,saij , Ahmedabad -Mehasana highway, AT&PO, Ta, saij, kalol -382725, Gandhinagar
Gandhinagar
GUJARAT
382725
India |
| Phone |
9558121886 |
| Fax |
|
| Email |
vishal12solanki@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD- 04,Department of Kayachikitsa,PSAM, Shree swaminarayan ayurvedic college, opp GIDC,saij , Kalol,Ahmedabad -Mehasana highway, AT&PO, saij, Ta, kalol , Gandhinagar-382725, State -Gujarat, Country - India |
|
|
Primary Sponsor
|
| Name |
Shree swaminarayan ayurvedic college kalol |
| Address |
Faculty of Ayurved, Shree Swaminarayan Ayurvedic College,
Ahmedabad-Mehsana Highway, AT&PO. Saij, Ta. Kalol, Dist.
Gandhinagar- 382725 |
| 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 Nehaben Arvindbhai Chauhan |
Teaching Hospital of Shree Swaminarayan ayurvedic College |
OPD-004 Department
of Kayachikitsa
Premswarup Swami
Ayurvedic Multispecialty hospital,Saij,Kalol-382725
Ahmedabad-Mehsana
Highway,AT&PO.Saij,T
a,Kalol Dist.Gandhinag
ar-382725
GUJARAT
Gandhinagar
GUJARAT |
8401334056
www.nehachauhantempo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shree Swaminarayan Ayurvedic College and Hospital, Kalol |
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: Truptighna dashemani , Reference: Charak samhita sutrasthan adhyay 4 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -lukewarm water ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nisha Amalaki churna , Reference: Charak samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -lukewarm water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patients of age 25 to 60 years 2.urine glucose level maximum 250mg/dl 3.blood glucose level maximum 300mg/dl 4.the patients presenting with the classical signs and symptoms like prameha according to Ayurveda and Type 2 diabetes mellitus according to modern science will be taken. |
|
| ExclusionCriteria |
| Details |
1.patients below 25years and above 60years of age 2.urine glucose level more than 250mg/dl 3.blood glucose level more than 300mg/dl 4.pregnant lady 5.totally and partially insulin dependent patients 6.serious systemic illness like Diabetes insipidus, chronic kidney disease, ischemic heart disease, autoimmune and endocrine disease,metabolic syndrome etc. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Truptighna dashemani tablet in prameha(Type 2 diabetes mellitus) |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Nisha -Amalaki churna in prameha(Type 2 diabetes mellitus) |
1 month |
|
|
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)
|
25/06/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Prameha commonly known as Diabetes in modern science,is a metabolic disorder which causes blood and urine glucose level high, burning in both sole extremities, general debility. Ayurvedic medicines offers holistic approaches to manage such a conditions, including the use of herbal formulations like, Truptighna dashemani and nisha amalaki churna. A comparative clinical study enrolled 40 participants with clinically diagnosed Type 2 diabetes mellitus . Participants were administered Truptighna dashemani or nisha amalaki churna orally for 30 days. The study demonstrated significant improvements in blood and urine glucose level , burning in both sole extremities, general debility, etc among participants. |