| CTRI Number |
CTRI/2019/02/017470 [Registered on: 05/02/2019] Trial Registered Prospectively |
| Last Modified On: |
27/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of sciatica through enema and oral intake medicated oil. |
|
Scientific Title of Study
|
Randomized comparative clinical study of vajigandhadi taila matra basti and pana in the management of gridhrasi w.s.r lumbosacral radiculopathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr sanjay gupta |
| Designation |
Associate professor dept.of panchakarma rishikul campus haridwar |
| Affiliation |
Dept.of panchakarma rishikul campus haridwar uttrakhand ayurved university 249401 |
| Address |
13 nand niwas harinagar haridwar
13 nand niwas harinagar haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411754007 |
| Fax |
|
| Email |
Ayursanjay44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sanjay gupta |
| Designation |
Associate professor dept.of panchakarma rishikul campus haridwar |
| Affiliation |
Dept.of panchakarma rishikul campus haridwar uttrakhand ayurved university 249401 |
| Address |
13 nand niwas harinagar haridwar
13 nand niwas harinagar haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411754007 |
| Fax |
|
| Email |
Ayursanjay44@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sanjay gupta |
| Designation |
Associate professor dept.of panchakarma rishikul campus haridwar |
| Affiliation |
Dept.of panchakarma rishikul campus haridwar uttrakhand ayurved university 249401 |
| Address |
13 nand niwas harinagar haridwar
13 nand niwas harinagar haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411754007 |
| Fax |
|
| Email |
Ayursanjay44@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rishikul campus |
| Address |
Rishikul campus, U.A.U., haridwar. |
| 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 |
| Anil kumar |
Rishikul campus UAU, haridwar |
Dept.of panchakarma rishikul campus uttrakhand ayurved university haridwar 249401
Hardwar
UTTARANCHAL |
9926883253
aniltripathi0000@gmail.Com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
| Institutional ethical committee |
Approved |
| Institutional ethical committee |
Approved |
| Institutional ethical committee |
Approved |
| Institutional ethical committee |
Approved |
| Institutional ethical committee |
Approved |
| Institutional ethical committee |
Approved |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Vajigandhadi taila matra basti 60 ml for 14 days two sittings with seven days gap. |
| Comparator Agent |
Group B |
Vajigandhadi taila pana 20ml/day with warm water for 14 days two turns with seven days gap at during meal time (annakala) in empty stomach, when one feels hungry. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Daignosed cases of gridhrasi(lumbosacral radiculopathy)
Patient daiagnosed of lumbago based upon investigation
History of lumbosal sprain/strain/ lumbago for more than six months |
|
| ExclusionCriteria |
| Details |
Uncontrolled diabetes mellitus
Uncontrolled T.B.of spine & hip joint
Uncontrolled hypertention
Malignancy of spine or other or organs
Fracture related to spine
Cardiac disease(IHD, CAD, MI etc)
Anaemic(Hb% less than 7.00 mg/dl)
Pregnancy
Age group less than 20 years and greater than 60 years
Refferred low backache from pelvis, abdomen or thoracic disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Only objective parameters will be employed for the assessment of the impact of treatment procedures in the respective group.
Complete remission-100%
Markedly improved-76-99%
Moderately improved-51-75%
Improved - 26-50%
Unchanged - 0-25% |
Only objective parameters will be employed for the assessment of the impact of treatment procedures in the respective group.
Complete remission-100%
Markedly improved-76-99%
Moderately improved-51-75%
Improved - 26-50%
Unchanged - 0-25% |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Excerbation in sign & symptoms |
42 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
08/02/2019 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Trial is started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Trial is going on.. |