| CTRI Number |
CTRI/2023/04/051562 [Registered on: 12/04/2023] Trial Registered Prospectively |
| Last Modified On: |
06/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of nutritive values of ashtaguna manda and its effect in improving the agni |
|
Scientific Title of Study
|
Standardization and evaluation of nutritive values of ashtaguna manda followed by assessment of its deepana-pachana effect in mandagni |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anita patiya |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of swasthavritta and yoga
National institute of ayurveda,deemed to be university jorawar singh gate,amer road jaipur (raj)-302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9826604387 |
| Fax |
|
| Email |
sanupatiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kashinath Samagandi |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of swasthavritta and yogaÂ
National institute of ayurveda,deemed to be university jorawar singh gate,amer road jaipur (raj)-302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7877444353 |
| Fax |
|
| Email |
kashisri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anita Patiya |
| Designation |
PG SCHOLAR |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of swasthavritta and yoga
National institute of ayurveda,deemed to be university jorawar singh gate,amer road jaipur (raj)-302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9826604387 |
| Fax |
|
| Email |
sanupatiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda pharmacy department jaipur,Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Department of Swasthavritta and Yoga,National Institute of Ayurveda Jaipur, Rajasthan, 302002 |
| Type of Sponsor |
Other [Government ayurveda college 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 Anita patiya |
National Institute of Ayurveda Jaipur and associated hospitals |
Department of Swasthavritta and Yoga, National Institute of Ayurveda
Jaipur
RAJASTHAN |
9826604387
sanupatiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
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: MANDAGNIH/Â AGNISADA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: No any alteration will be advised in Dinacharya Practices , Ritucarya: No any alteration will be advised in Ritucharya Practices , Acara Rasayana:No any alteration will be advised in Acara Rasayana Practices , Other:Pathya Will be advised for Agnimandhya Patient, Pathya/Apathya:yes, Pathya:Astaguna Manda in Mandhagni Patients, Apathya:As per the classical references |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
• Irrespective of Gender, Religion and Caste
• Age between 18-50 years
• Mandagni since10 Days
• Person having aversion to medicine
• Person having aversion/unwillingness towards
physical activities
|
|
| ExclusionCriteria |
| Details |
• Acute Medical conditions
• Psychological Disturbances
• Psychological Eating Disorders
• Persons consuming any kind of medication for
systemic disorders and health status
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Standard operating procedure of preparation of Ashtaguna Manda and determination of nutritive and caloric values. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reliving the complaints of Mandagni after administration of Ashtaguna Manda |
7 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2023 |
| 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
|
NILL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
· The mere changes in diet can be an answer to most of the health-related issues faced by people worldwide. Ayurvedic food recipes can be a boon to this scenario. But if the recipes are not made according to the classical way, it may lack some properties and thus affect its effectiveness. The contemporary world demands recipes or food preparations with a tag of their nutritive values. So, there is a need of standardization of these recipes along with the evaluation of their nutritive values for their global acceptance and propagation. · The clinical application of these recipes along with medication provides an add-on effect and they are capable of exhibiting their benefits even when they are used alone. · In this study, standardization of Ashtaguna Manda followed by evaluation of its nutritive values and Deepana-Pachana effect in Mandagni will be done. · In this study Ashtaguna Manda is taken, that described in Yogaratnakar. The reason for choosing is the standardization needs proper quantity of ingredients is well described here. Also, the era of Yogaratnakar is the latest so closely related to the present |