| CTRI Number |
CTRI/2025/06/088225 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the effect of Laaja saktu in management of Urdhwag Amlapitta in 60 participants. |
|
Scientific Title of Study
|
A randomised control trial to evaluate the effect of Laaja Saktu in the management of Urdhwaga Amlapitta. |
| 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 Snehal Satish Aher |
| Designation |
PG Student |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalay, Hadapsar |
| Address |
Special OPD no 3, Department of Swasthavritta and Yoga, Sane guruji Arogya Kendra, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9763148462 |
| Fax |
|
| Email |
snehal.aher357@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Ujwale |
| Designation |
HOD Department of Swasthavritta and Yoga |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalay, Hadapsar |
| Address |
Special OPD no 3, Department of Swasthavritta and Yoga, Sane guruji Arogya Kendra, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9922008027 |
| Fax |
|
| Email |
ujwale_rs@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Ujwale |
| Designation |
HOD Department of Swasthavritta and Yoga |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalay, Hadapsar |
| Address |
Special OPD no 3, Department of Swasthavritta and Yoga, Sane guruji Arogya Kendra, Hadapsar, Pune
MAHARASHTRA
411028
India |
| Phone |
9922008027 |
| Fax |
|
| Email |
ujwale_rs@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Swasthavritta and Yoga, Hadapsar, Pune 28 |
|
|
Primary Sponsor
|
| Name |
Sane guruji Arogya Kendra |
| Address |
Special OPD no 3, Department of Swasthavritta and Yoga, Sane guruji Arogya Kendra, Hadapsar, Pune |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Snehal Satish Aher |
Sane guruji Arogya Kendra, Hadapsar, Pune |
Special OPD no 3, Department of Swasthavritta and Yoga, Sane guruji Arogya Kendra, Hadapsar, Pune
Pune
MAHARASHTRA |
9763148462
snehal.aher357@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMS Sumatibhai Shah Ayurved Mahavidyalay and Sane guruji Arogya Kendra, Hadapsar, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Laaja saktu, Reference: Bhaishajyaratnawali , Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -), Additional Information: Sita churn as anupan 5 gm | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:, Apathya:Apathyakar ahar and vihar that aggravate pitta dosha and causes symptoms of Amlapitta which includes katu, amla, lavana rasatmak ahar, viruddhahar, divaswap and ratrijagaran.
|
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Recently diagnosed patients with Urdhwag Amlapitta |
|
| ExclusionCriteria |
| Details |
Diabetic patients
Patients with severe vomiting and diarrhea
Chronic disease like HIV, Tuberculosis and gastric ulcer
Pregnant and lactating mothers
Patients with drug induced hyperactivity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of lajasaktu in the management of Urdhwag Amlapitta. |
The parameters of efficacy of lajasaktu will be evaluated by observing patients through subjective criteria at regular intervals 0th,7th, 14th days follow up. The relief of sign and symptoms of Amlapitta will be evaluated with the help of questionnaire. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To prepare and standardize lajasaktu. To study effect of lajasaktu on Amlapitta. |
The parameters of efficacy of lajasaktu will be evaluated by observing patients through subjective criteria at regular intervals 0th,7th, 14th days follow up. The relief of sign and symptoms of Amlapitta will be evaluated with the help of questionnaire. |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/06/2025 |
| 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="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
|
The parameters of efficacy of lajasaktu will be evaluated by observing patients through subjective criteria at regular intervals 0th,7th, 14th days follow up. The relief of sign and symptoms of Amlapitta will be evaluated with the help of questionnaire. |