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CTRI Number  CTRI/2025/01/078978 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Management]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Yogasanas with sunthi powder in treating indigestion. 
Scientific Title of Study   A Comparative study to evaluate the efficacy of Sunthi churna Zingiber officinale with Yogasanas and Sunthi churna alone in Amajirna A Randomized control trial 
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 Shivani Samarth Kodape 
Designation  PG Scholar Department of Swasthavritta 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi  
Address  Room no 222 PG Department of Swasthavritta Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi

South West
DELHI
110073
India 
Phone  8411942233  
Fax    
Email  shivanikodape22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jai Singh Yadav 
Designation  Assistant Professor at PG Department of Swasthavritta 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi 
Address  Room no 230 PG Department of Swasthavritta Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi

South West
DELHI
110073
India 
Phone  7568730726  
Fax    
Email  dr_jaisinghyadav@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Jai Singh Yadav 
Designation  Assistant Professor at PG Department of Swasthavritta 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi 
Address  Room no 230 PG Department of Swasthavritta Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi

South West
DELHI
110073
India 
Phone  7568730726  
Fax    
Email  dr_jaisinghyadav@yahoo.co.in  
 
Source of Monetary or Material Support  
Chaudhary Brahm Prakash Ayurved Charak Sansthan khera dabar najafgarh new delhi 110073 
 
Primary Sponsor  
Name  Ch Brahm Prakash Ayurved Charak Sansthan 
Address  Khera Dabar Najafgarh New Delhi 110073 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivani Samarth Kodape  Ch Brahm Prakash Ayurved Charak Sansthan  OPD and IPD PG department of Swasthavritta Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh 110073 South West DELHI
South West
DELHI 		 8411942233

shivanikodape22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC CBPACS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: AMAJA-AJIRNAM/KAPAJA-AJIRNAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Yogasana (Procedure Reference: Gherand samhita, Hathayoga pradipika, Bihar books of yoga, Procedure details: Prayer, Sukshma Vyayam, Paschimottasana Matsyendrasana, Bhujangasana, Shalabhasana Pawanmuktasana, Vajrasan all asanas are advised for 30 days in sets of 5 for 20 secs empty stomach early in the morning. )
(1) Medicine Name: Sunthi, Reference: Bhavapraksh, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Duration: 1 Months
2Comparator ArmDrugClassical(1) Medicine Name: Sunthi, Reference: Bhavaprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -NIL
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Classical symptoms of Amajirna (Indigestion).

2. Patients of either sex and between 18-60 years of age.

3. Patients willing and able to carry out treatment for 30 days.

4. Patients will be registered with duly signed informed consent prior to the trial.

 
 
ExclusionCriteria 
Details  1.Patients with diagnosed cases of gastric, peptic and duodenal ulcers.

2.Patients with any GIT, abdominal complications and chronic illness.

3.Patients with diagnosed cases of any systemic disorder.

4.Pregnant and lactating women.

5.Patients suffering from raised intracranial pressure, hernia, diabetes with eye problems, heart problems.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
After completion of trial, results will be analysed and documented. Yogasanas are expected to reduce the symptoms of Amajirna.
 		 0th,15th,30th & 45th day 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in subjective parameters like 1.Guruta (heaviness in abdomen).
2.Utkleda (nausea).
3.Shotha gandakshikuta (swelling of cheeks and eyes).
4.Udgar (belching).
5.Prasek (salivation).
 		 0th, 15th, 30th & 45th day. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 
Date of First Enrollment (India)   16/02/2025 
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="0"
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   The study is randomized control trial to compare the effect of yogasana with sunthi churna or sunthi churna alone in Amajirna. In one group sunthi churna with warm water will be given and in other group sunthi churna with yogasanas ( Paschimottanasana, matseyndrasana,bhujangasana, shalabasana, vajrasana and pawanmuktasana ) will be given for 30 days, follow up on 15th & 30th day. The trial will be conducted in Ch. brahm prakash ayurved charak sansthan with outcome ; Yogasanas are expected to reduce the symptoms of Amajirna. Improvement in subjective parameters of Amajirna.

 

 
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