| CTRI Number |
CTRI/2018/08/015484 [Registered on: 28/08/2018] Trial Registered Prospectively |
| Last Modified On: |
17/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of punarnavadi ghan vati and sallaki on Gridhrasi. |
|
Scientific Title of Study
|
A Comparative Clinical Study Of Punarnavadi Ghan Vati And Sallaki In Management Of 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 Pavan Pramod Behare |
| Designation |
PG Registrar |
| Affiliation |
College of Ayurved and Research Centre Akurdi Pune |
| Address |
Plot no 492 Shramsaphalya shivaji chauk A/p virdel tal shindkheda dist Dhule
Collage of ayurvede and research centre set. 25 pradhikaran nigdi pune 411044
Pune
MAHARASHTRA
425406
India |
| Phone |
9403430422 |
| Fax |
|
| Email |
chinupatil1224@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr medha mahesh joshi |
| Designation |
PG Registrar |
| Affiliation |
College of Ayurved and Research Centre Akurdi Pune |
| Address |
A1 WING flat no 20 RAHUL PARK WARJE PUNE
Collage of ayurvede and research centre set. 25 pradhikaran nigdi pune 411044
Pune
MAHARASHTRA
411058
India |
| Phone |
9881465798 |
| Fax |
|
| Email |
medhamaheshjoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavan Pramod Behare |
| Designation |
PG Registrar |
| Affiliation |
College of Ayurved and Research Centre Akurdi Pune |
| Address |
Plot no 492 shramsaphalya shivaji chauk A/p virda tal shindkheda dist Dhule
Collage of ayurvede and research centre set. 25 pradhikaran nigdi pune 411044
Pune
MAHARASHTRA
425406
India |
| Phone |
9403430422 |
| Fax |
|
| Email |
chinupatil1224@gmail.com |
|
|
Source of Monetary or Material Support
|
| All drug purchase from manakarnika aushadhalaya and authenticated from Agharkar Research Institute Pune |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Pavan Pramod Behare |
AYURVED RUGNALAY AND STERLING MULTISPESHALITI HOSPITAL |
KAYACHIKITA DEPARTMENT ROOM NO 117 SECTOR NO 27 PRADHIKARAN NIGADI PUNE 411044
Pune
MAHARASHTRA |
9403430422
chinupatil1224@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| College of Ayurved and Research Centre Nigdi pune |
Approved |
| Maharashtra University of Health Sciences, Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G570||Lesion of sciatic nerve, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
Punarnavadi Ghana Vati |
Punarnavadi Ghana Vati 500mg twice a day Oraally for 1 month |
| Comparator Agent |
Tab Sallaki |
Tab Sallaki 400mg twice a day Orally for 1 month |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients showing classical symptoms and sign of Gridhrasi as described in
ayurvedic samhitas as Charak Chikitsasthan 28/57,58.
- Radiating pain along the course and distribution of sciatic nerve that is in buttock
to outer border of foot.
2. SLR Test of patient – positive upto 60 degree.
3. Patients between the age of 25-70 years.
4. Patients from all socio-economic status.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating mothers.
2. Infective disorders – T.B. spine, osteomyelitis.
3. Patients with paraplegia of lower limb.
4. Fracture of spinal bones or in lower extremity bones
5. Patients having congenital anamolies with lumbosacral spine such as kyphosis,
scolisis.
6. Patients having any major chronic/acute; systemic/surgical pathology like
malignancies.
7. Patients with deep wounds penetrating till sciatic nerve.
8. Patients with dislocation of hip joint, amputation above knee joint.
9. Patient having symptoms caused by prolonged pressure on hip like comatosed
patients.
10. Patients having allergy to any content of drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
According to improvement grading of fallowing signs and symtoms in 1 month:
1. Padashoola (pain)
2. Katishoola
3. Stambha (stiffness)
4. Toda (pricking sensation)
5. Spandan (twitching)
6. Dehasya –Api-Pravakrata (Gait)
7. Straight Leg Rising Test (SLRT) |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study adverse effects if any in |
1 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/08/2018 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The current project aims to compare efficacy of punarnavadi ghana vati ani tab. sallaki in management of Gridhrasi.
HYPOTHESIS:
H0; punarnavadi ghana vati, 500mg in vyanodan kaal for 30 days, is not significantly effective than tab. sallaki, 400mg in vyanodan kaal for 30 days in the management of Gridhrasi.
H1: punarnavadi ghana vati 500mg in vyanodan kaal for 30 days is more effective than tab. sallaki 400mg in vyanodan kaal for 30 days in the management of Gridhrasi. |