| CTRI Number |
CTRI/2025/07/090906 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding the enhancement of Mandagni (low digestive fire) through activation of the Manipura Chakra (Solar plexus Chakra) by Yogasanas and chanting of the Mantra. |
|
Scientific Title of Study
|
Clinical Study to evaluate the effect of Manipura Chakra Activation by Yogasanas and Mantra Uccharana on Mandagni |
| 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 Deorshi Ashok Kate |
| Designation |
MD Scholar, Samhita and Siddhanta |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
| Address |
OPD no 14A Swasthavritta Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Aurangabad, 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8830491949 |
| Fax |
|
| Email |
dakate1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pritam Jayprakash Rathi |
| Designation |
Associate Professor |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
| Address |
Department of Samhita and Siddhanta, CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Aurangabad, 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9767035230 |
| Fax |
|
| Email |
drpritamrathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deorshi Ashok Kate |
| Designation |
MD Scholar, Samhita and Siddhanta |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
| Address |
Department of Samhita and Siddhanta, CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Aurangabad, 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8830491949 |
| Fax |
|
| Email |
dakate1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Aurangabad, Maharashtra, India, 431011 |
|
|
Primary Sponsor
|
| Name |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
| Address |
Kanchanwadi, Aurangabad, Maharashtra, India, 431011 |
| 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 Deorshi Ashok Kate |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
OPD no 14A Swasthavritta Department, Aurangabad, Maharashtra, India
Aurangabad
MAHARASHTRA |
8830491949
dakate1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CSMSS Ayurved Mahavidyalaya and Rugnalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: MANDAGNIH/ AGNISADA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Yogasanas, Ritucarya: N/A, Acara Rasayana:N/A, Other:Beejamantra chanting, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients showing classical Lakshanas of Mandagni.
2)The patients will be taken irrespective of cast, gender, religion, occupation and economical status.
3)The patients willing to trail and giving written consent.
4)Patients who are not under any treatment for Mandagni. |
|
| ExclusionCriteria |
| Details |
1)The patients suffering from sever Gastro Intestinal diseases and major diseases.
2)Age group Below 18 to above 30 years.
3)Pregnant women and lactating mothers.
4)Patients having any direct or indirect trauma to spine/vertebral column.
5)Patients who are not capable to do Yogasanas. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Adhamana(Distension of abdomen), Aatopa and Aantrakujana(Gurgling Sounds of the Intestine), Gauravam(Heaviness of Abdomen) Lakshanas will be decreased
|
Baseline, 16th day, 31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Aasyashosha(Dryness of mouth)
Annam chiratpachet(Food digest slowly)Lakshanas will be decreased |
Baseline, 16th day, 31st 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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
|
Written informed consent will be taken. Initial assesment on 1st day(Baseline). Suggest Yogasanas and Beeja Mantra Chanting. The demonstration of yogasanas will be conducted in an organized and structured manner. Follow up on 16th and 31st day. Observations will be noted. Statistical analysis Conclusion will be carried out on the basis of overall assessment of obtained data. |