| CTRI Number |
CTRI/2025/02/080886 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the efficacy of Triphaladi Kwath in management of Prameha |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Triphaladi Kwath in the management of prameha w.s.r. to diabetes mellitus type-2 |
| 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 Ankit Yadav |
| Designation |
PG Scholar |
| Affiliation |
Kunwar Shekhar Vijender Ayurved Medical College & Research Center |
| Address |
Department of kayachikitsa Adarsh institutional area Babu Vijendra marg Gangoh
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
7737058001 |
| Fax |
|
| Email |
Ankity421@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AP Singh |
| Designation |
Professor & HOD |
| Affiliation |
Kunwar Shekhar Vijender Ayurved Medical College & Research Center |
| Address |
Department of kayachikitsa Adarsh institutional area Babu Vijendra marg Gangoh
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9410088322 |
| Fax |
|
| Email |
apsingh11264@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AP Singh |
| Designation |
Professor & HOD |
| Affiliation |
Kunwar Shekhar Vijender Ayurved Medical College & Research Center |
| Address |
Department of kayachikitsa Adarsh institutional area Babu Vijendra marg Gangoh
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9410088322 |
| Fax |
|
| Email |
apsingh11264@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kunwar Shekhar Vijender Ayurved Medical College & Research Center Department of kayachikitsa Adarsh institutional area Babu Vijendra marg Gangoh Saharanpur Uttar pradesh India 247341 |
|
|
Primary Sponsor
|
| Name |
Dr ANKIT YADAV |
| Address |
Kunwar Shekhar Vijender Ayurved Medical College & Research Center Department of kayachikitsa Adarsh institutional area Babu Vijendra marg Gangoh Saharanpur Uttar pradesh 247341 |
| 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 ANKIT YADAV |
Kunwar Shekhar Vijender Ayurved Medical College & Research Center |
Adarsh institutional area Babu Vijendra marg Gangoh
Saharanpur
UTTAR PRADESH |
7737058001
Ankity421@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KSVAMC-IEC |
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: Triphaladi Kwath , Reference: Dr. Indradeva Tripathi, Chakradatta of Sri Chakrapanidatta With the Vaidayaprabha Hindi Commentary, Chaukhamba Sanskrit Bhawan Varanasi, chapter-35, shloka-21page-217, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject of age group between 20 and 60 years and irrespective of caste, sex, religion, occupation, and socio-economic status.
2. Subject with classical signs and symptoms will be included.
3. Disease chronicity less than 5 years
4. Non Insulin Dependent Diabetes Mellitus
5. Subject willing to give informed consent to participate for 60 days. |
|
| ExclusionCriteria |
| Details |
1. Patients below 20 and above 60 years of age
2. Patients suffering from other systemic disorders like renal or cardiac disorders
3. Sahaja and Jataja Madhumeha, i.e. DM Type 1 patients
4. Patient on insulin therapy
5. Pregnant and lactating womens
6. Patients with diabetic gangrene carbuncles and other complications of diabetes like diabetic nephropathy and diabetic retinopathy
7. Diabetic ketoacidosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in sign and symptoms of Prameha |
75 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cost effective treatment and to observe if there are any adverse effect |
75 days |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
17/03/2025 |
| 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="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
|
Nowadays, scholars of various disciplines are working on the problem, and various modern means and measures have been discovered, even than an effective drug without any side effects could not be stabilized. This highlights the need for clinical research in suitable designs to evaluate the efficacy of Ayurveda drugs in the treatment of Diabetes mellitus. No research work or documentation is available on the study of Triphaladi Kwath in the management of Prameha. Therefore, in this present study, it has been taken as a trial drug. Triphaladi Kwath which is mentioned in Chakradatta chapter 35th Pramehachikitsa Prakaranam Shloka 21, has Katu, Tikta, Kashaya Rasa dominance, along with Madhur, Amla, & Laghu, Ruksha Guna help in alleviation of Kapha. Considering all the aspects, the present study has been framed to compare the efficacy of Triphaladi Kwath. Subjects of either gender diagnosed with Prameha whose age group is between 20 to 60 years old will be selected. Triphaladi Kwath will be given to the subject orally in dosage of 48ml twice daily 1 hour before meals with Madhu as Anupana for 60 days. The assessment will be done on the 0th day, 30th day, 60th day and 75th day (15 days after completion of intervention) by using subjective parameters and objective parameters. |