| CTRI Number |
CTRI/2018/08/015187 [Registered on: 03/08/2018] Trial Registered Prospectively |
| Last Modified On: |
03/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Chikitsa of Vataja Pinasa with Shodhana Basti and Nasya |
|
Scientific Title of Study
|
A Role of Dosha Nirharana In The Management of Vataja Pinasa-A Comparative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krunal Chandana |
| Designation |
MS (Pg Scholar) |
| Affiliation |
Government Akhandanand Ayurveda Mahavidhyalaya |
| Address |
Opd 10 Department Of Shalakya Tantra Government Akhandanand Ayurveda Mahavidhyalaya Bhadra Ahemedabad
Gujarat
Ahmadabad
GUJARAT
380001
India |
| Phone |
9099490146 |
| Fax |
|
| Email |
drkrunalchandana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemangi B Shukla |
| Designation |
Reader |
| Affiliation |
Government Akhandanand Ayurveda Mahavidhyalaya |
| Address |
Opd 10 Department Of Shalakya Tantra Government Akhandanand Ayurveda Mahavidhyalaya Bhadra Ahemedabad
Gujarat
Ahmadabad
GUJARAT
380001
India |
| Phone |
9825504280 |
| Fax |
|
| Email |
drhemangishukla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krunal Chandana |
| Designation |
MS (Pg Scholar) |
| Affiliation |
Government Akhandanand Ayurveda Mahavidhyalaya |
| Address |
Opd 10 Department Of Shalakya Tantra Government Akhandanand Ayurveda Mahavidhyalaya Bhadra Ahemedabad
Gujarat
Ahmadabad
GUJARAT
Dr KRUNAL CHANDANA
India |
| Phone |
9099490146 |
| Fax |
|
| Email |
drkrunalchandana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurveda Mahavidhyalaya Bhadra Ahemedabad
Gujarat
|
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurveda Mahavidhyalaya |
| Address |
Government Akhandanand Ayurveda Mahavidhyalaya Bhadra Ahemedabad
Gujarat
|
| 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 Krunal Chandana |
Government Akhandanand Ayurveda Mahavidhyalaya |
Opd 10 Department Of Shalakya Tantra Government Akhandanand Ayurveda Mahavidhyalaya Bhadra Ahemedabad
Gujarat
Ahmadabad
GUJARAT |
9099490146
drkrunalchandana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients suffering from vataja pinasa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
management of vataj pinasa with sakshar ghritapan, anutaila nasya and shodhana basti |
15 pts taken in one group and will be treated with shodhana basti in following dose and duration:
sakshar ghritapan 20ml-5days
anutail nasya 8-8 drops- 7 days
shodhan basti 960 ml - 3 days |
| Comparator Agent |
managment of vataj pinas with sakshar ghritapan and anutaila nasya |
15 pts taken in one group and will be treated with sakshar ghritapan and anutaila nasya in following dose and duration:
sakshar ghritapan 20ml-5days
anutail nasya 8-8 drops- 7 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Sign & Symptoms of Pakva vataja Pinasa
2.Basti yogya
3.Nasya yogya
4.Snehan yogya
|
|
| ExclusionCriteria |
| Details |
1.The person with age of <18 and>60years
2.Aamavstha of Vataja Pinasa :(The following lakshanas of Amavastha will be excluded in it’s excessive state.)
Aruchi
Mukha Vairasya
Shirogurutva
Kshvathu
Ruja
Arati
Jwara
Tanu Srava
Sthivana
Kshina Swara
3.Basti ayogya
4.Nasya ayogya
5.Snehana ayogya
6.Nasa Arsha
7.Nasa Arbuda
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All the Sign and Symptoms of Vataja Pinasa will be assigned score depending upon their severity to assess the effect of the drugs at the time of before and after treatmnet |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All the sign and symptoms of vataja pinasa will be assigned score depending upon their severity to the effect of the drugs at the time of before and after treatmnet |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
06/08/2018 |
| 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="5"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of the Study is to know the efficacy of Shodhana Basti in the management of Vataja Pinasa in Trial group. The Study is Randomised, Patient selection is blinded. Nasya and Basti will be given as per S.O.P. |