| CTRI Number |
CTRI/2019/09/021295 [Registered on: 17/09/2019] Trial Registered Prospectively |
| Last Modified On: |
14/09/2019 |
| 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
|
a clinial study to evaluate the the effect of purgation with Trivritadi kwath and drug effect with avipattikar churna in the management of Heart Burning in Acidity. |
|
Scientific Title of Study
|
"A comparative study to evaluate the effect of Virechan Karma with Trivartadi Kwath and Shaman chikitsa with Avipattikar Churn of Urodaha (retrosternal burning) In Amplapitta ( Acid peptic disorder)". |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritesh |
| Designation |
PG scholar |
| Affiliation |
Ch.brahm prakashayurveda charak sanstan |
| Address |
Near community center state bank of india khera dabar najafgarh new delhi 110073
Near community center state bank of india khera dabar najafgarh new delhi 110073
South West
DELHI
110073
India |
| Phone |
9460082040 |
| Fax |
|
| Email |
drrpoonia1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Gupta |
| Designation |
Professor pg dept of panchkarma |
| Affiliation |
Ch.brahm prakash ayurveda charak sanstan |
| Address |
Room no 238 panchkarma department chaudhary brahm prakash ayurved charak santhan, khera dabar new delhi
Girls hostel Panchkarma department chaudhary brahm prakash ayurved charak santhan, khera dabar new delhi
South West
DELHI
110073
India |
| Phone |
8178361290 |
| Fax |
|
| Email |
Arun24@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritesh |
| Designation |
PG Scholar dept of Panchkarma |
| Affiliation |
ch.brahm prakash charak ayurveda sansthana |
| Address |
CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN,Panchkarma department KHERA DABAR, NEW DELHI
CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN, Panchkarma department KHERA DABAR, NEW DELHI
South West
DELHI
110073
India |
| Phone |
7412993810 |
| Fax |
|
| Email |
Drrpoonia1992@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch.brahm prakash Ayurvad charak sathan new delhi |
|
|
Primary Sponsor
|
| Name |
Choudhary brahm prakash charak ayurveda sansthana |
| Address |
Choudhary brahm prakash charak ayurveda sansthana khera daber najafgarh 110073 |
| Type of Sponsor |
Government 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 Arun gupta |
Ch.brahm prakash ayurvadic charak sathan new delhi |
ROOM NO 238 Ch.brahm prakash ayurvadic charak sathan new delhiKhera dabar najafgarh new delhi 110073
South West
DELHI |
817861290
arun24@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ch brahm prakash charak ayurveda sansthana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K219||Gastro-esophageal reflux disease without esophagitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Saman chikitsa with drug |
Avipatikar chrun given for 15 day |
| Intervention |
Virechana Karma |
Virechana Karma with Trivritadi Kwath which follow below schedule
Deepan Pachan -3 days
Abhyanta Snehapaa - 3 to 7 days
Vishrama kala- 2 days
Virchana yoga - 1 day
Sansarjana Krama - 3 to 7 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either gender diagnosed as a case of Amalpitta and undergoing Virechana or Shamana chikitsa as per SOP.
2.Patients between age group of 20-50yrs.
|
|
| ExclusionCriteria |
| Details |
1.Patients reporting with complications like Cardiac problems, emphysema, carcinoma, etc. will be excluded.
2.Pregnant woman and lactating mothers will be excluded.
• Patient taking anti-inflammatory medications.
• Patients of severe vomiting and dehydration
7
1 Patients with gastric malignancy
2 Patients who recently undergone gastrointestinal surgery
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce in symptoms of Amalpitta |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce in symptoms of amalpitta |
15 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
21/09/2019 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
the study is open label parallel group trail comparing the efficacy of virechana karma with trivritadi kwath and avipattikar churn in the management of amalapitta.dose of trivritadi kwath is according to kostha and dose of avipttikar churn is 5 gm bd 15 days.the trial will be conducted in chaudhary brahm prakash ayurveda charak sansthan khera dabar with primary outcome on symptom of amalpitta. |