| CTRI Number |
CTRI/2019/07/020301 [Registered on: 22/07/2019] Trial Registered Prospectively |
| Last Modified On: |
20/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of purgation treatment followed by oil enema treatment in paralysis. |
|
Scientific Title of Study
|
A clinico-comparative study of Koshtha Shodhana prior to Matra Basti in the management of Pakshaghata. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divyaraj Gadhavi |
| Designation |
P.G. Scholar, Parul Institute of Ayurved. |
| Affiliation |
Parul Institute of Ayurved. |
| Address |
Panchkarma Department,
Parul Institute of Ayurved,
Parul University,
Po.Limda, Waghodia,
Vadodara-391760
Panchkarma Department,
Parul Institute of Ayurved,
Parul University,
Po.Limda, Waghodia,
Vadodara-391760
Vadodara
GUJARAT
391760
India |
| Phone |
7411834142 |
| Fax |
|
| Email |
divy11093@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K B Roy |
| Designation |
Professor, Parul Institute of Ayurved. |
| Affiliation |
Parul Institute of Ayurved. |
| Address |
Panchkarma Department,
Parul Institute of Ayurved,
Parul University,
Po.Limda, Waghodia,
Vadodara-391760
Panchkarma Department,
Parul Institute of Ayurved,
Parul University,
Po.Limda, Waghodia,
Vadodara-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9825912141 |
| Fax |
|
| Email |
dr_kbroy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K B Roy |
| Designation |
Professor, Parul Institute of Ayurved. |
| Affiliation |
Parul Institute of Ayurved. |
| Address |
Panchkarma Department,
Parul Institute of Ayurved,
Parul University,
Po.Limda, Waghodia,
Vadodara-391760
Panchkarma Department,
Parul Institute of Ayurved,
Parul University,
Po.Limda, Waghodia,
Vadodara-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9825912141 |
| Fax |
|
| Email |
dr_kbroy@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurved Hospital,
Parul University,
Po. Limda, Waghodiya,
Vadodara-391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Panchkarma Department,
Parul Institute of Ayurved,
Parul University,
Po. Limda, Waghodia,
Dist. Vadodara- 391760 |
| Type of Sponsor |
Private 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 |
| Divyrajsinh Bhupendrasinh Gadhavi |
Parul Institute of Ayurved |
Panchkarma Department,
Parul Institute of Ayurved,
Parul University,
po. Limda, Waghodia,
Dist. Vadodara- 391760
Vadodara
GUJARAT |
7411834142
divy11093@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Koshtha Shodhana with 30 ml Eranda Taila orally with warm water prior to Matra Basti of Sahachar Taila |
Eranda Taila 30 ml for 1 day
warm water
Sahachara Taila 72 ml for 15 days
|
| Intervention |
Matra Basti 72 ml of Sahachar taila |
Sahachar Taila 72 ml Matra Basti for 15 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical signs and symptoms of Pakshaghata.
|
|
| ExclusionCriteria |
| Details |
Patients with uncontrolled metabolic and systemic disorders.
Patients suffering from cerebral, cerebellar atrophy or any intracranial infectious diseases.
Comatose patients.
Intracranial space occupying lesions and trauma.
patients suffering from bladder and bowel incontinence. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| obtaining of Samyaka Matra Basti Lakshana |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Chestha Nivvritti, Hasta Pada Sankochana, Ruja, Vak Aspastata |
4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2019 |
| 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
|
not publish yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Matra Basti is a type of Sneha Basti explained by Acharya Charaka. It can be given daily and any time. The dose for the Matra Basti is Hrasva Matra of Snehapana that is approx around 72 ml. Matra Basti is having minimum chances for complications. Matra Basti is having good results in Vatavyadhis. Virechana is a prime line of treatment in the management of Pakshaghata. Here is an attempt of trial that one group will be treated with koshtha shodhana in the form of mridu virechana with 30 ml of Eranda Taila follwed by 15 days Matra Basti and another group will be treated with Matra Basti with Sahachar taila for 15 days. |