| CTRI Number |
CTRI/2025/07/091615 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on the effect of Yava-Amlaka Churna with Warm Water and Triphala with Honey in Obesity |
|
Scientific Title of Study
|
A comparative clinical study of yava amlaka churna with ushnodaka and triphala with madhu in sthaulya. |
| 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 Shubham Chaudhary |
| Designation |
MD SCHOLAR |
| Affiliation |
Uttaranchal Ayurvedic College |
| Address |
Post Graduate Department of Samhita And Siddhant, Uttaranchal Ayurvedic College
17 Old Mussoorie Road, Rajpur,
Dehradun, Uttarakhand,(India)
Dehradun
UTTARANCHAL
248179
India |
| Phone |
9720155000 |
| Fax |
|
| Email |
drshubhamchaudhary00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ved Bhushan Maithani |
| Designation |
Associate Professor |
| Affiliation |
Uttaranchal Ayurvedic College |
| Address |
Post Graduate Department of Samhita And Siddhant, Uttaranchal Ayurvedic College
17 Old Mussoorie Road, Rajpur,
Dehradun, Uttarakhand,(India)
Dehradun
UTTARANCHAL
248179
India |
| Phone |
8006875328 |
| Fax |
|
| Email |
shekharmaithani19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Chaudhary |
| Designation |
MD SCHOLAR |
| Affiliation |
Uttaranchal Ayurvedic College |
| Address |
Post Graduate Department of Samhita And Siddhant, Uttaranchal Ayurvedic College
17 Old Mussoorie Road, Rajpur,
Dehradun, Uttarakhand,(India)
Dehradun
UTTARANCHAL
248179
India |
| Phone |
9720155000 |
| Fax |
|
| Email |
drshubhamchaudhary00@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttaranchal Ayuvedic College,17 Old Mussoorie Road, Pincode 248009, Rajpur,
Dehradun, Uttarakhand, (India) |
|
|
Primary Sponsor
|
| Name |
Uttaranchal Ayuvedic College |
| Address |
17 Old Mussoorie Road,Pincode - 248009, Rajpur, Dehradun, Uttarakhand, (India) |
| 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 Shubham Chaudhary |
PG Department of Samhita And Siddhant, UTTARANCHAL AYURVEDIC COLLEGE , Dehradhun |
OPD 10, PG Department of Samhita And Siddhant, 17 Old Mussoorie Road, Rajpur,
Dehradun, Uttarakhand,(India)
Dehradun
UTTARANCHAL |
9720155000
drshubhamchaudhary00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UTTARANCHAL AYURVEDIC COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Kshudha Adhikya – Excessive hunger
Trishna Adhikya – Excessive thirst
Nidra Adhikya – Excessive sleep
shudra Svasa – Shortness of breath on exertion
Klanta – Fatigue or tiredness
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala Churna , Reference: Astanga Hrudyam , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 120 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yava Amalaka Churna , Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 120 Days, anupAna/sahapAna: Yes(details: -Luke Warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient irrespective of both sex.
Patients between the age 20-50 years will be selected.
Patients diagnosed as a case of Sthaulya.
Patients with Sthaulya having symptoms like Nidra Adhikya, Sweda Adhikya, daugandya, Kranta, Angasada and Trishna Adhikya.
Patient willingness to enroll in study. |
|
| ExclusionCriteria |
| Details |
Patient not including under the above criteria.
Patient having any chronic illness like cancer, Diabetes mellitus, Hyperthyrodism, drug intake patients, autoimmune disease, smoking alcoholic etc.
Patient not willing to enroll the study.
Grade III Obese persons. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of yava amalaka churna with ushnodaka vis a vis Triphala Churna with madhu will be assessed for the treatment of sthaulya |
120 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
04/08/2025 |
| 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="0"
Months="4"
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
|
STUDY PROTOCOL SUMMARY
1. Material and Methods
a) Material
Subjects/Sample Collection**: A total of 60 patients will be selected using the simple random sampling method. Patients will be taken from the OPD of Samhita and Siddhant, Swasthvritta, and Kayachikitsa departments of Uttaranchal Ayurvedic Hospital.
Drugs and References
References: Charak Samhita 21/23 and Ashtang Hrudayam Sutra 14/22. All ingredients for Triphala Churna and Madhu, as well as for Yava Amlaka Churna, will be sourced from the college pharmacy. Churna will be prepared under the supervision of the Rasashastra and Bhaishajya Kalpana department, following classical methods to maintain quality.
b) Method
Type of Study Randomized controlled trial with comparative analysis before and after treatment. Sample Size 60 patients, randomly selected.
Group A: 30 patients will receive Yava Amlaka Churna. Group B: 30 patients will receive Triphala Churna.
Diagnostic Criteria
Subjective Parameters
Excessive hunger (Kshudha Adhikya) Excessive thirst (Trishna Adhikya) Excessive sleep (Nidra Adhikya) Shortness of breath on exertion (Kshudra Swasa) Fatigue (Klanta) Weakness or inability to perform activities (Akshamta)
Objective Parameters
Random Blood Sugar (RBS) Height Weight Abdominal circumference Waist circumference Hip circumference Waist-hip ratio Body Mass Index (BMI)
Inclusion Criteria
Patients showing signs and symptoms according to diagnostic criteria Male and female patients between the ages of 20 to 50 Diagnosed cases of Sthaulya (obesity) Patients with symptoms like excessive sleep, sweating, body odor, fatigue, body heaviness, and thirst Willingness to participate in the study
Exclusion Criteria
Patients not meeting the above diagnostic criteria Patients with chronic illnesses such as cancer, diabetes mellitus, hyperthyroidism, or those taking regular medications Patients with autoimmune diseases, smokers, alcoholics Unwilling participants Grade III obese individuals
|