| CTRI Number |
CTRI/2025/04/084669 [Registered on: 13/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of result of Paribhdra & Amlaki kwath in Amlapitta(Hyperacidity) disease |
|
Scientific Title of Study
|
Pharmacotherapeutic evaluation of Paribhadra Patra (Erythrina variegata Linn.) and Amlaki phala (Emblica officinalis Gaertn.) in the management of Amlapitta (Hyperacidity) - An exploratory study |
| 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 Kalpana Poonia |
| Designation |
PG scholar |
| Affiliation |
Post Graduate Institute of Ayurveda DSRRAU Jodhpur |
| Address |
PG Department of DravyaGuna PGIA DSRRAU JODHPUR
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8824705009 |
| Fax |
|
| Email |
kalpana0210poonia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Poonia |
| Designation |
PG scholar |
| Affiliation |
Post Graduate Institute of Ayurveda DSRRAU Jodhpur |
| Address |
PG Department of DravyaGuna PGIA DSRRAU JODHPUR
RAJASTHAN
342037
India |
| Phone |
8824705009 |
| Fax |
|
| Email |
kalpana0210poonia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Kumar Adlakha |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Ayurveda DSRRAU Jodhpur |
| Address |
PG Department of DravyaGuna PGIA DSRRAU JODHPUR
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166639579 |
| Fax |
|
| Email |
drmanojarora2503@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIA jodhpur Rajasthan India 342037 |
|
|
Primary Sponsor
|
| Name |
PGIA DSRRAU Jodhpur |
| Address |
PG Department of DravyaGuna PGIA DSRRAU Jodhpur Rajasthan , 342037, India |
| Type of Sponsor |
Government 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 Kalpana Poonia |
Sanjeevani Hospital |
department of dravyaguna vigyan PGIA DSRRAU Jodhpur Rajasthan , 342037,India
Jodhpur
RAJASTHAN |
8824705009
kalpana0210poonia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituational Ethics Committee Dr sarvepalli radhakrishnan rajasthan ayurveda university Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K318||Other specified diseases of stomach and duodenum. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Paribhadra patra kwath, Reference: Harit samhita 24/4, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Clinically and pathologically diagnosed patient , who are suffering from Amlapitta |
|
| ExclusionCriteria |
| Details |
1. Subject should not suffering from Amlapitta more than 3 months
2. Age below 16 years and above 50 years
3. Subject reporting with complication like cardiac problem , emphysema, carcinoma etc. will be excluded
4. Pregnant woman and lactating mothers was excluded
5. Subject with gastric malignancy
6. Subject who recently undergo gastro-intestinal surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the objective parameters |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the clinical sign and symptoms of Amlapitta |
1 month |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="0"
Months="6"
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
|
My study titled "Pharmacotherapeutical Evaluation of Paribhadra Patra and Amalaki Phala in the Management of Amlapitta (Hyperacidity)" focuses on assessing the effectiveness of two traditional Ayurvedic remedies—Paribhadra Patra (leaves of Erythrina variegata) and Amalaki Phala (fruit of the Indian gooseberry)—in treating Amlapitta, commonly known as hyperacidity. The research evaluates the pharmacological properties, therapeutic actions, and potential benefits of these remedies in alleviating symptoms such as indigestion, acidity, and gastritis. The study aims to provide scientific evidence supporting their use in managing hyperacidity and offers insights into their mechanisms of action, dosage, and safety profile in the context of Ayurvedic treatment practices. |