| CTRI Number |
CTRI/2020/09/027573 [Registered on: 03/09/2020] Trial Registered Prospectively |
| Last Modified On: |
25/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of dietics in Amlapitta (Acid Peptic disorder) |
|
Scientific Title of Study
|
Role of dwadasha ashana pravichara w.s.r. Food Chronobiology in maintenance of Agni in Amlapitta (Acid Peptic disorder)A Randomised Control Clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sadaf Khan |
| Designation |
MD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no. 720 ,7th floor,Department of Samhita Siddhanta ,All India Institute of Ayurveda,Gautampuri ,Sarita Vihar,Mathura Road ,New Delhi-110076
New Delhi
DELHI
110076
India |
| Phone |
9971402184 |
| Fax |
|
| Email |
sadafkhan55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahesh K Vyas |
| Designation |
Prof. and HOD |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no. 716 ,7th floor,Department of Samhita Siddhanta ,All India Institute of Ayurveda,Gautampuri ,Sarita Vihar,Mathura Road ,New Delhi-110076
New Delhi
DELHI
110076
India |
| Phone |
8849802005 |
| Fax |
|
| Email |
drmaheshkvyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sadaf Khan |
| Designation |
MD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no. 720 ,7th floor,Department of Samhita Siddhanta ,All India Institute of Ayurveda,Gautampuri ,Sarita Vihar,Mathura Road ,New Delhi-110076
New Delhi
DELHI
110076
India |
| Phone |
9971402184 |
| Fax |
|
| Email |
sadafkhan55@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda,Gautampuri ,Sarita Vihar,Mathura Road ,New Delhi-110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda,Gautampuri,Sarita Vihar,Mathura Road,New delhi-110076 |
| 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 |
| Sadaf Khan |
All India Institute of Ayurveda |
Opd no.5 & 7,ground floor,opd block, All India Institute of Ayurveda,Gautampuri ,Sarita Vihar,Mathura Road ,New Delhi-110076
New Delhi
DELHI |
9971402184
sadafkhan55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Guduchi churna |
oral administration of Guduchi churna in dose of 3gms twice daily for duration of 1 month |
| Intervention |
Patients of amlapitta will be advised dwadasha ashana pravichra. |
Advice dwadasha ashana pravichara for the duration of 1 month |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having clinical symptoms of Amlapitta(Acid peptic disorder).
2. Individual between age group20 to 50 years irrespective of gender, education and socio economic status etc
|
|
| ExclusionCriteria |
| Details |
1-Patient with grave diseases, complications, and other co-morbidities will be excluded.
2-Patient who are suffering from other, systemic disorder, metabolic disorders like
diabetes, hypertension, etc will be excluded.
3-Pregnant and Lactating Females
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess the role of Dwadasha ashana pravavichara, especially food chronobology in proper functioning of Agni. |
one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study role of deterrence in Dwadasha ashana pravavichara,as Nidana of Amlapitta(Acid Peptic Disorder) .
2. To study the role of food chronobiology in treatment of Amplapitta(Acid Peptic Disorer)
|
one month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2020 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Clinical study will be carried out in the patients of Amlapitta ,to assess the role of
properly following Dwadasha ashana
pravavichara,The well diagnosed patients of Amlapitta will be selected and randomly
divided in to 2 groups.One group will be given guduchi churna and other group will be advised to follow the rules mentioned in dwadasha ashana pravichara.After the trial of one month the patient will be examined for the symptoms and effect will be evaluated.The patient will be followed up for a period of one month. |