| CTRI Number |
CTRI/2019/10/021757 [Registered on: 22/10/2019] Trial Registered Prospectively |
| Last Modified On: |
11/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study of Sahacharadi oil Matra Basti (enema) Panchkarma with Tila (Sesame) oil Matra Basti (enema) in Gridhrasi (Scietica). |
|
Scientific Title of Study
|
A comparative clinical study of Sahacharadi Taila Matra Basti with Tila Taila Matra Basti in Gridhrasi. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Milind Kamble |
| Designation |
MD Student |
| Affiliation |
Sane guruji Arogya Kendra |
| Address |
Department of Panchakarma
Sumatibhai shah Ayurved college and Hospital
Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9960275868 |
| Fax |
|
| Email |
mkamble1191@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Avhad |
| Designation |
Reader |
| Affiliation |
Sane guruji Arogya Kendra |
| Address |
Department of Panchakarma
Sumatibhai shah Ayurved college and Hospital
Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9890608788 |
| Fax |
|
| Email |
drvandanapalve@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milind Kamble |
| Designation |
MD Student |
| Affiliation |
Sane guruji Arogya Kendra |
| Address |
Department of Panchakarma
Sumatibhai shah Ayurved college and Hospital
Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9960275868 |
| Fax |
|
| Email |
mkamble1191@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sumatibhai Shah Ayurved college and Hospital Hadapsar Pune |
|
|
Primary Sponsor
|
| Name |
Dr Milind Kamble |
| Address |
Dept of Panchkarma
Sumatibhai Shah Ayurved and Hospital Hadapasar Pune |
| 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 |
| Dr Milind Kamble |
Sumatibhai shah ayurved college and hospital |
Room no 6
Dept of Panchakarma
Sane Guruji Arogya Kendra
Hadapsar Pune
Pune
MAHARASHTRA |
9960275868
mkamble1191@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC MAMs Sumatibhai Shah Ayurved Mhavidyalaya and Sane guruji Arogya Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sahacharadi Tail |
60 ml Basti per rectum for 8 days |
| Comparator Agent |
Til tail |
60 ml basti per rectum for 8 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of Gridhrasi with symptoms like Ruja Stambha Spandana Tandra Gaurava Arochak
Basti Arha indicated
|
|
| ExclusionCriteria |
| Details |
Patient of Cardiovascular disorder renal disorder Diabetes mellitus other systemic diseases
Pregnancy and lactating mother
K/C/O Fracture related to spine
Basti Anarha not indicated
|
|
|
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 |
| To compare the effect of Sahcharadi taila matra basti with Tila taila matra basti in Gridhrasi |
8 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To assess the effect of Sahacharadi taila matra basti in Gridhrasi
2 To assess the effect of Tila taila matra basti in Gridhrasi |
8 days |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 3 |
|
Date of First Enrollment (India)
|
03/02/2020 |
| 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) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Not yet decided |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
1. Patients will be selected by Randomized sampling method. 2. Patients from Panchakarma Kaychikitsa and Shalyatantra OPD and IPD will be identified in the recruiting in the study. 3. Proper screening of patients will be done for selection to fulfill the inclusion and exclusion criteria. 4. 62 Patients of Gridhrasi (Scitica) will be purposively selected in OPD /IPD basis irrespective of Gender Economic status Religion and Occupation. 5. Assessment will be done Pre-Post Treatment Follow up and data collection done. 6. Explain of purpose of nature of study will be given to the patient selected after screening. 7. The patient willing to sign the inform consent form will be recruited for the study and will be maintained in detail case paper. 8. Assessment will be done on 0 day, 4th day, 7th day, 15th day. Follow up on 30thday. |