| CTRI Number |
CTRI/2022/08/045093 [Registered on: 30/08/2022] Trial Registered Prospectively |
| Last Modified On: |
28/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
To Study the effect of Lifestyle modification with special reference to aharvidhividhan and Bhojanottarvidhi vidhan( Rules of dietic)on Agnimandya |
|
Scientific Title of Study
|
A Randomized Clinical Trial to Study the Effect of Lifestyle Modification with special reference to Aharvidhividhan and Bhojanottar vidhividhan on Agnimandya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pallavi Narendra Agarkar |
| Designation |
PG Scholar |
| Affiliation |
Vidarbha Ayurved mahavidyalaya |
| Address |
vidarbha Ayurved Mahavidyalaya,
Chatri Talao Road,Near Farsi Stop Amravati
Amravati
MAHARASHTRA
444601
India |
| Phone |
9834645280 |
| Fax |
|
| Email |
drpallaviagarkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay K Chopkar |
| Designation |
Guide and HOD Department of Swasthvritta and Yoga |
| Affiliation |
Vidarbha Ayurved mahavidyalaya |
| Address |
vidarbha Ayurved Mahavidyalaya,
Chatri Talao Road,Near Farsi Stop Amravati
Amravati
MAHARASHTRA
444601
India |
| Phone |
9423105104 |
| Fax |
|
| Email |
skchopkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi Narendra Agarkar |
| Designation |
PG Scholar |
| Affiliation |
Vidarbha Ayurved mahavidyalaya |
| Address |
vidarbha Ayurved Mahavidyalaya,
Chatri Talao Road,Near Farsi Stop Amravati
Amravati
MAHARASHTRA
444601
India |
| Phone |
9834645280 |
| Fax |
|
| Email |
drpallaviagarkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidarbha Ayurved Mahavidyalaya Amravati |
|
|
Primary Sponsor
|
| Name |
Vidarbha Ayurved Mahavidyalaya Amravati |
| Address |
Chatri Talao Road,Near Farsi Stop, Amravati |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Pallavi Narendra Agrakar |
Vidarbha Ayurved Mahavidyalaya and Hospital Amravati |
OPD no 12, Department of Swastha vritta and Yoga
Vidarbha Ayurved Mahavidyala Hospital
Chatri Talao road, Near Farsi Stop Amravati
Amravati
MAHARASHTRA |
9834645280
drpallaviagarkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.H.V.P.M. Vidarbha Ayurved mahavidyalaya Amravati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: Agnimandya, (2) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: MANDAGNIH/Â AGNISADA, (3) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: Agnimandya, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trikatu Churna, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: - | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Aharvidhividhan and bhojanottar vidhi vidhan,, Pathya/Apathya:yes, Pathya:Follow : Aharvidhividhan and bhojanottar vidhi vidhan,, Apathya:Avoiding Aharvidhividhan and bhojanottar vidhi vidhan, |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
subject having signs and symptoms of agnimandya
like
avipak,
prasek,
kshudhamandya,
Shirogaurav,
Amashay pradeshi gaurav,
Shirogaurav,
Antrakujan,
Pravahan,
malbaddhata,
Jaran shakti,
Abhyavharan Shakti,
Mala samata
patient having any 2 or more symptoms among these.
having symptoms not more than 2 months. |
|
| ExclusionCriteria |
| Details |
patient age less than 20 and more than 60 years,
patients diagnosed with any pathology of GIT such as Cancer of GIT, Liver, pancreas, gall bladder, peptic and gastric ulcer, gastro-esophageal reflux, gall stone, renal failure, hepatitis, tuberculosis will be excluded.
pregnant and lactating mother,
people not ready to give written consent, and
not ready to change their lifestyle due to occupation or duties.
Agnimandya caused due to medicine intake. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete Remission from Agnimandya 76-100%
Marked Improvement in Agnimandya 51-75%
mild improvement in Agnimandya 25-50% |
0th day
3rd Day
7th Day
14th Day
21st Day
28th Day
35th Day
42nd Day
49th Day
56th Day
63th Day
70th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Remission in symptoms of anaemia
Remission in symptoms of obesity
weight gain in thin built persons (Karshya) |
0th day
14th day
35th day
49th day
70th day |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
31/08/2022 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Randomized clinical trial will be conducted to study the effect of Lifestyle modification with special reference to Aharvidhividhan and Bhojanottar vidhividhan on Agnimandya. Trial will be conducted in our Institute . total 120 patients with Inclusive Criteria having Signs and symptoms of Agnimandya will be selected and will be divided in two groups. one group will be advised Lifestyle modifications i.e Aharvidhividhan and Bhojanottar vidhividhan and other group will be observed only. and result will be compared. Primary outcome will be about Evaluation of Lifestyle distrubance and the Secondary Outcome will be about assessment criteria of effect of therapy. and results will be noted |