| CTRI Number |
CTRI/2025/03/081847 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
29/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study of Yavadi Churna and Eladi Churna for Managing Urdhvaga Amlapitta W.S.R to non-ulcer dyspepsia |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Trial to Evaluate the Efficacy of Yavadi Churna and Eladi Churna in the Management of Urdhvaga Amlapitta (Non-Ulcer Dyspepsia) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohit Yashwantrao Deshmukh |
| Designation |
PG SCHOLAR |
| Affiliation |
SST Ayurved Mahavidyalaya, Sangamner |
| Address |
SST Ayueved Mahavidyalaya, Kayachikitsa Department OPD No. 6, Front of prasad hotel, Pune- Nashik Highway, Sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8007597365 |
| Fax |
|
| Email |
rohitdeshmukh11@icloud.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Swati Prafull Soman |
| Designation |
Professor |
| Affiliation |
SST Ayurved Mahavidyalaya, Sangamner |
| Address |
SST Ayueved Mahavidyalaya, Kayachikitsa Department OPD No. 6, Front of prasad hotel, Pune- Nashik Highway, Sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9421438178 |
| Fax |
|
| Email |
swati.soman68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Rohit Yashwantrao Deshmukh |
| Designation |
PG SCHOLAR |
| Affiliation |
SST Ayurved Mahavidyalaya, Sangamner |
| Address |
SST Ayueved Mahavidyalaya, Kayachikitsa Department OPD No. 6, Front of prasad hotel, Pune- Nashik Highway, Sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8007597365 |
| Fax |
|
| Email |
rohitdeshmukh11@icloud.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SST Ayurved Mahavidyalaya Sangamner |
| Address |
SST Ayueved Mahavidyalaya, Kayachikitsa Department OPD No. 6, Front of prasad hotel, Pune- Nashik Highway, Sangamner dist - Ahmadnagar
pin code - 422605 |
| 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 Yashwantrao Deshmukh |
SST Ayurved Mahavidyalaya, Sangamner |
SST Ayueved Mahavidyalaya, Kayachikitsa Department OPD No. 6, Front of prasad hotel, Pune- Nashik Highway, Sangamner, 422605
Ahmadnagar
MAHARASHTRA |
8007597365
rohitdeshmukh11@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sst ayurved mahavidyalaya sangamner Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K90-K95||Other diseases of the digestive system. Ayurveda Condition: URDHVAGATA-AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yavadi churna, Reference: yogratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Eladi churna, Reference: Yogratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. age group 18-50 years
2. sex both male & female
3. pt fulfilling the diagnostic criteria which are based on sign and symptoms of urdhvaga amlapitta such as avipaka, utklesha, tikta amla udgara, gaurava, hrutkantadaha, aruchi, klama |
|
| ExclusionCriteria |
| Details |
1. pregnant & lactating mothers
2. k/c/o DM, HTN, malignant, bleeding disorders
3. any other addictions like chronic alcoholism induced hyperacidity
4. k/c/o systemic disorders
5. k/c/o H. pylori infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the symptoms of urdhvaga amlapitta |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the digestive system to reduce the symptoms of amlapitta |
21 Days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="1" |
|
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
|
it is a randomized comparative clinical trial to evaluate the efficacy of yavadi churna and eladi churna in the management of urdhvaga amlapitta with age group between 18 to 50 years both male and female simple size is 40 patient in each group |