| CTRI Number |
CTRI/2020/10/028246 [Registered on: 06/10/2020] Trial Registered Prospectively |
| Last Modified On: |
24/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [other (clinical)] |
| Study Design |
Other |
|
Public Title of Study
|
Panchakarma Treatment in Paralysis |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Effect Of Nasya In The Management Of Pakshaghat w.s.r Hemiplegia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pushpinder Singh |
| Designation |
H.O.D ,Panchkarma Department |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital ,Paprola ,H.P |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital,Paprola ,District-Kangra , Himachal Pradesh
176115 ,India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8580789117 |
| Fax |
|
| Email |
drpushpinderpk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushpinder Singh |
| Designation |
H.O.D ,Panchkarma Department |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital ,Paprola ,H.P |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital,Paprola ,District-Kangra , Himachal Pradesh
176115 ,India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8580789117 |
| Fax |
|
| Email |
drpushpinderpk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geeta Devi |
| Designation |
2nd Year PG Scholar ,Panchkarma Department |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital ,Paprola ,H .P |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital,Paprola ,District-Kangra , Himachal Pradesh
176115 ,India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8988891400 |
| Fax |
|
| Email |
geeta3747@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, RGGPG Ayurvedic College and Hospital, Paprola ,Kangra (H.P) |
| K.L. Mehta & Co.,Bazar Wahian Wala ,Majith Mandi ,Amritsar(Punjab) |
| Research Institute in I.S.M. Jogindernagar (H.P.) |
|
|
Primary Sponsor
|
| Name |
Principal Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola ,District Kangra ,Himachal Pradesh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pushpinder Singh |
RGGPG Ayurvedic College and hospital |
Room no: 203, Department of Panchkarma, Rajiv Gandhi Govt. PG Ayurvedic College & Hospital, Paprola
Kangra
HIMACHAL PRADESH |
8580789117
drpushpinderpk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC(human) RGGPG Ayurvedic college ,Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dashpaak Bala Taila Nasya |
Snehana Nasya with Dashpaak Bala Taila will be given in dose of 16 bindu in each nostril daily once for 10 days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing for the study.
2.Fully conscious patient.
3.Patient having spastic hemiplegia.
4.Patient having CVA due to Ischaemic lesion.
5.Patient fit for Nasya. |
|
| ExclusionCriteria |
| Details |
1.Patient not willing for the study
2.Not fully conscious patient.
3.Patient having flaccid hemiplegia.
4.Patient having CVA due to Haemmorhagic lesion
5.Chronicity more than 1 year.
6.Patient having Comorbidities like Coronary
Artery Disease ,Chronic Kidney disease,
Uncontrolled diabetes ,Uncontrolled hypertension .
7.Patient not fit for nasya.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of objective and subjective criteria |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General feeling of well being |
17 days |
|
|
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)
|
12/10/2020 |
| 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="0"
Months="3"
Days="0" |
|
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)?
Response - NO
|
|
Brief Summary
|
I would like to publish my research study after completion of the trial as soon as possible. Patients will be selected from OPD and IPD of RGGPG Ayurvedic College and Hospital ,Paprola ,District -Kangra (H.P).One group of 10 patients will be registered and then assessed on the basis of assesment criteria to know the effect of nasya in management of Pakshaghat. |