| CTRI Number |
CTRI/2020/12/029829 [Registered on: 15/12/2020] Trial Registered Prospectively |
| Last Modified On: |
22/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study on the effect of vyoshadya oil matra basti in the management of gridhrasi(sciatica) |
|
Scientific Title of Study
|
clinical study on the effect of vyoshadya oil matra basti in the management of gridhrasi(sciatica) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati Singh |
| Designation |
MD SCHOLAR (Panchkarma) |
| Affiliation |
Dr D. Y Patil Ayurveda College and Research Centre |
| Address |
O.P.D-9 PANCHKARM DEPT Dr D.Y Patil Ayurveda College and Research Centre, Sant Tukaram nagar pimpri, pune 411018
Dr D.Y Patil Ayurveda College and Research Centre, Sant Tukaram nagar pimpri, pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8795969000 |
| Fax |
|
| Email |
drswatis20@gmai.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali R Chaudhari |
| Designation |
MD PANCHKARMA |
| Affiliation |
Dr D. Y Patil Ayurveda College and Research Centre |
| Address |
O.P.D-9 PANCHKARM DEPT Dr D.Y Patil Ayurveda College and Research Centre, Sant Tukaram nagar pimpri, pune 411018
Dr D.Y Patil Ayurveda College and Research Centre, Sant Tukaram nagar pimpri, pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9822964710 |
| Fax |
|
| Email |
vaishalidhandes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali R Chaudhari |
| Designation |
MD PANCHKARMA |
| Affiliation |
Dr D. Y Patil Ayurveda College and Research Centre |
| Address |
O.P.D-9 PANCHKARM DEPT Dr D.Y Patil Ayurveda College and Research Centre, Sant Tukaram nagar pimpri, pune 411018
Dr D.Y Patil Ayurveda College and Research Centre, Sant Tukaram nagar pimpri, pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9822964710 |
| Fax |
|
| Email |
vaishalidhandes@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D.Y Patil Ayurveda College and Research Centre, Sant tukaram nagar Pimpri, Pune 411018 |
|
|
Primary Sponsor
|
| Name |
Swati Singh |
| Address |
Dr D.Y Patil Ayurveda College and Research Centre ,Sant Tukaram nagar pimri, pune 411018 Maharashtra |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Vd Vaishali Chaudhari |
O.P.D-9 PANCHKARMA DEPTDr D.Y Patil Ayurveda College and Research Centre |
Dr. D.Y Patil Ayurveda College and Research Centre, Sant tukaram nagar Pimpri, Pune 18
Pune
MAHARASHTRA |
9822964710
vaishalidhandes@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
NIL |
| Intervention |
Vyoshadya oil Matra Basti |
Vyoshadya oil (60ml) is administeration in anus for 9 days |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Presence of symptops like Shoola(pain), Toda(Pricking pain sensation) and Stambha(Stiffness) in the Sphik, Kati, Uru and Pada Pradesh(Lumber region).
2) Patient fit for basti and give written consent.
3) SLR (STRAIGHT LEG TEST) POSITIVE.
|
|
| ExclusionCriteria |
| Details |
1) Benigne or malignant tumour of spine or TB of vertebral column.
2) Patient with history of trauma causing fracture.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vyoshadya oil matra basti is effective in gridhrasi(scitica) |
9 days study with 2 follow up(0,9,18 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in grades of Gridhrasi will be studied. |
9 days study with 2 follow up (0,9,18days) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2 |
|
Date of First Enrollment (India)
|
30/12/2020 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study the effect of Vyoshadya oil matra basti in 50 patients of gridhrasi(sciatica). Total 50 will be enrolled for 9 days. For 9 days 60ml of vyoshadya oil will be given throgh anal opening and monitering the effect |