| CTRI Number |
CTRI/2018/04/013196 [Registered on: 12/04/2018] Trial Registered Prospectively |
| Last Modified On: |
05/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Management Of Pakshaghata.Inability to move hands and legs of one side of body. |
|
Scientific Title of Study
|
A COMPARITIVE CLINICAL STUDY TO RULE OUT THE EFFECT OF KARPASASTHYADI TAILA AND MASHA TAILA NASYA 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 |
Shipra Raheja |
| Designation |
PG SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVED |
| Address |
Parul institute of Ayurved,A/P-Limda Tal-Waghodia,Dist-Vadodara,Gujarat. PIN-391760
India.
Parul institute of Ayurved,A/P-Limda Tal-Waghodia,Dist-Vadodara,Gujarat. PIN-391760
India.
Vadodara
GUJARAT
39176
India |
| Phone |
9467043379 |
| Fax |
02668260201 |
| Email |
shipragenius1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohini Salve |
| Designation |
Associate Professor |
| Affiliation |
PARUL INSTITUTE OF AYURVED. PARUL UNIVERSITY |
| Address |
Parul institute of Ayurved,A/P-Limda Tal-Waghodia,Dist-Vadodara,Gujarat. PIN-391760
India.
Parul institute of Ayurved,A/P-Limda Tal-Waghodia,Dist-Vadodara,Gujarat. PIN-391760
India.
Vadodara
GUJARAT
39176
India |
| Phone |
9467043379 |
| Fax |
02668260201 |
| Email |
rohinirakesh2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shipra Raheja |
| Designation |
PG SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVED |
| Address |
Parul institute of Ayurved,A/P-Limda Tal-Waghodia,Dist-Vadodara,Gujarat. PIN-391760
India.
chandar Nagar Society, House No.203, Vrindavan Chowkdi, Waghodia Road, Vadodara, Gujarta
Vadodara
GUJARAT
39176
India |
| Phone |
9467043379 |
| Fax |
02668260201 |
| Email |
shipragenius1@gmail.com |
|
|
Source of Monetary or Material Support
|
| PARUL INSTITUTE OF AYURVED And Hospital |
|
|
Primary Sponsor
|
| Name |
SHIPRA RAHEJA |
| Address |
Parul institute of Ayurved,A/P-Limda Tal-Waghodia,Dist-Vadodara,Gujarat. PIN-391760
India. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ROHINI SALVE |
Parul institute of Ayurved,A/P-Limda Tal-Waghodia,Dist-Vadodara,Gujarat. PIN-391760
India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shipra Raheja |
Parul institute of Ayurved and hospital |
Panchkarma dept. opd no. 113 Parul institute of Ayurved,A/P-Limda Tal-Waghodia,Dist-Vadodara,Gujarat. PIN-391760
India.
Vadodara
GUJARAT |
9467043379
shipragenius1@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 |
Paralysis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Karpasthyadi taila nasya |
The karpasthyadi tail contents karpasasthi,bala, masha,kultha,devdaru,rasna, kustha,sarshap,nagra,sahatahava,pippalimoola,aja ksheera, til taila , all drugs will be taken and make taila preparation by classical method. |
| Comparator Agent |
Masha taila nasya |
The Masha tail contents are Masha , aatmgupta,Bala, urobuk,rasna aswghnada, rohitak ,hingu and saindhva tila tail all will be taken and tail will be prepared by classical method . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with classical sign and symptoms of Pakshaghata Ischemic patients with stable vitals . |
|
| ExclusionCriteria |
| Details |
Patients with uncontrolled metabolic disorders , and other systemic disorders ,
Unconscious Patients, Paralysis complicated with heart diseases |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| scoring of importance of Nasya procedure in the management of Pakshghata for improvement of disability of patients |
scoring of importance of nasya procedure in the management of pakshghata for improvement of disability of patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IMPROVEMENT IN GENERAL LIFE OUTCOME OF PATIENTS OF PAKSHAGHATA |
21 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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
05/05/2018 |
| 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="1"
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
|
hypothesis - Karpasthyadi tail nasya is effective in pakshghata Masha taila nasya is effective in pakshaghat Both are equql effective in pakshaghata . Pakshaghata is a disease in which the person is unable to move his limbs and do day to day work. so here is an effoert to improve the general disability and functions in patients by a procedure called Nasya. |