| CTRI Number |
CTRI/2019/06/019784 [Registered on: 20/06/2019] Trial Registered Prospectively |
| Last Modified On: |
18/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of ayurveda enema in heart disease |
|
Scientific Title of Study
|
The Efficacy of Punarnavadi Anuvasna Basti in Hrudroga w.r.t. Valvular Heart Disease – An 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 LATISHA LAXMAN KOMARPANT |
| Designation |
PG Scholar |
| Affiliation |
KAHER’S Shri B.M.K. Ayurveda Mahavidyalaya Post Graduate Studies And Research centre |
| Address |
KAHER’S
Shri B.M.K. Ayurveda Mahavidyalaya
Post Graduate Studies And Research centre
Shahapur, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9923466672 |
| Fax |
|
| Email |
komarpantlatisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR LATISHA LAXMAN KOMARPANT |
| Designation |
PG Scholar |
| Affiliation |
KAHER’S Shri B.M.K. Ayurveda Mahavidyalaya Post Graduate Studies And Research centre |
| Address |
KAHER’S
Shri B.M.K. Ayurveda Mahavidyalaya
Post Graduate Studies And Research centre
Shahapur, Belagavi
KARNATAKA
590003
India |
| Phone |
9923466672 |
| Fax |
|
| Email |
komarpantlatisha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAJASHEKHAR V SANAPETI |
| Designation |
Reader Department of Panchakarma |
| Affiliation |
KAHER’S Shri B.M.K. Ayurveda Mahavidyalaya Post Graduate Studies And Research centre |
| Address |
KAHER’S
Shri B.M.K. Ayurveda Mahavidyalaya
Post Graduate Studies And Research centre
Shahapur, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9611442881 |
| Fax |
|
| Email |
rajashekharpk@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER’S
Shri B.M.K. Ayurveda Mahavidyalaya
Post Graduate Studies And Research centre
|
|
|
Primary Sponsor
|
| Name |
DR LATISHA LAXMAN KOMARPANT |
| Address |
KAHER’S
Shri B.M.K. Ayurveda Mahavidyalaya
Post Graduate Studies And Research centre
Shahapur, Belagavi-590003 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR LATISHA LAXMAN KOMARPANT |
KLE Ayurveda Hospital |
OPD No 04 and OPD No 01 and IPD of KLE Ayurveda Hospital Shahapur Belgaum - 590003
Belgaum
KARNATAKA |
9923466672
komarpantlatisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KAHERs Shri B M K Ayurveda Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Punarnavadi Anuvasna Basti (Medicated Enema Treatment) |
Patient will be administered with 75ml of Punarnavadi taila after food through rectal route for 7days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient presenting with the Symptoms of VHD- Chest pain, dyspnoea, pedal oedema, fatigue.
2. K/C/O Valvular heart disease
3. Age between 20 – 70 years
4. Patient fit for basti.
5. On medication drugs will be continued.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from Valvular heart disease with:
1. Congestive cardiac failure (CCF)
2. Coronary Artery Disease (CAD)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Punarnavadi anuvasna basti effective in treating Valvular Heart Disease.
|
0th, 8th, 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
01/01/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The overall prevalence of moderate or severe Valvular Heart disease is estimated at 2.5% with no sex difference, from 0.7% in those aged 18-44years to 13.3%in those aged<75years. Valvular Heart Disease encompasses a condition which accounts for 10% to 20% all cardiac surgical procedures. In contemporary medical science the conservative measures taken to treat VHD has long term usage that has potential side effects with economic burden. Hence Basti treatment could be a safer, cost effective for the betterment of the patient. |