| CTRI Number |
CTRI/2020/11/028908 [Registered on: 04/11/2020] Trial Registered Prospectively |
| Last Modified On: |
29/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Treatment of Amlapitta through Yoga |
|
Scientific Title of Study
|
Effect of Vamana Dhauti In The Management of Amlapitta- An Exploratory Open Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vani V Adake |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Hospital Shahapur Belagavi |
| Address |
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi
Swasthavritta OPD No 2
Belgaum
KARNATAKA
590003
India |
| Phone |
8496851247 |
| Fax |
|
| Email |
vanivadake@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev S Tonni |
| Designation |
Reader |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Hospital Shahapur Belagavi |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Swasthavritta OPD No 2
Belgaum
KARNATAKA
590003
India |
| Phone |
9448543858 |
| Fax |
|
| Email |
sanjeevtonni@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev S Tonni |
| Designation |
Reader |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Hospital Shahapur Belagavi |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Swasthavritta OPD No 2
Belgaum
KARNATAKA
590003
India |
| Phone |
9448543858 |
| Fax |
|
| Email |
sanjeevtonni@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Researches owned Shri B M Kankanawadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Vani V Adake |
| Address |
PG Scholar
Department of Swasthavritta
KAHERs Shri B M K Ayurveda Mahavidyalaya
Shahapur
Belagavi |
| 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 |
| Dr Vani V Adake |
KAHERs Shri B M Kankanawadi Ayurveda Hospital Shahapur Belagavi |
OPD No 2 and OPD No 4
Belgaum
KARNATAKA |
8496851247
vanivadake@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: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Vamana Dhauti |
Patients will be administered Vamana dhauti once in a week for 1 month. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients fit for Vamana Dhauti
2 Known cases of Amlapitta |
|
| ExclusionCriteria |
| Details |
1 Known cases of peptic ulcer, duodenal ulcer, carcinoma stomach, cardiac disorders, hypertension, diabetes mellitus, and chronic renal failure.
2 Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There may be a good reduction in symptomatology of the patient even with the non-pharmacological intervention, so that, the burden of everyday medication could be minimised or reduced to nil. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analysis of the vaanta dravya (Vomitus) for its Organo-leptic and Physico-chemical properties |
18 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
12/11/2020 |
| 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="1"
Months="6"
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
|
Amlapitta adversely affects the quality of life of patients, making it difficult to make dietary choices and causing insomnia even hampering social life and contributes to medical expenses. So, considering the above factors, the clinical study will be conducting to assess the effect of Vamana dhauti, one among the purification procedures explained for upper gastro-intestinal tract, which is very simple to administer, cost effective and feasible in all seasons. |