| CTRI Number |
CTRI/2021/06/034067 [Registered on: 08/06/2021] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effectiveness of Krushna Churna and Parijatak Gugulu in the treatment of
Gridhrasi (Sciatica) |
|
Scientific Title of Study
|
A Randomized controlled clinical trial to evaluate efficacy between
Krushna Churna and Parijatak Gugulu in the 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 |
Prashant Dhondiram Chavan |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College of Ayurved and research center pradhikaran nigdi pune |
| Address |
PDEAs college of Ayurved and Research Centre, third floor kayachikitsa Department, sector 25 , Pradhikaran Nigdi , Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9421161159 |
| Fax |
|
| Email |
prashantchavan10692@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Khobragade |
| Designation |
Associate Professor Kayachikitsa Department |
| Affiliation |
PDEAS college of ayurved and research center pradhikaran nigdi pune |
| Address |
PDEAs college of Ayurved and Research Centre, third floor kayachikitsa Department, sector 25 , Pradhikaran Nigdi , Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8378929859 |
| Fax |
|
| Email |
khobragaderupali19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prashant Dhondiram Chavan |
| Designation |
PG scholar |
| Affiliation |
PDEAS college of Ayurved and research center pradhikaran nigdi pune |
| Address |
PDEAs college of Ayurved and Research Centre, third floor kayachikitsa Department, sector 25 , Pradhikaran Nigdi , Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9421161159 |
| Fax |
|
| Email |
prashantchavan10692@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre , sector 25, Pradhikaran Nigdi, Pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre Pradhikaran Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre , sector 25, Pradhikaran Nigdi, Pune 411044 |
| Type of Sponsor |
Private medical college |
|
|
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 Prashant Dhondiram Chavan |
PDEAS Ayurved Ruganalya and Sterling Multispeciality Hospital Nigdi Pradhikaran Pune |
Kayachikitsa department
O.P.D.no 117,Ground
floor,vithal rukmani road, bhel chowk, sector number 27, Nigdi Pradhikaran,
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9421161159
prashantchavan10692@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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:G00-G99||Diseases of the nervous system. Ayurveda Condition: Gridhrasi, (2) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Krushna Churna |
Group A will be treated with Krushna Churna which include Krushna (Piper
Longum
Linn)
krushna churna will be given orally in dose of 500mg with
gomutra10ml & eranda tail 5 ml two times a day in vyanodan kaal in 25-65year age group which includes followup on 7th, 14th, 21st ,28th day |
| Comparator Agent |
Parijatak Gugulu |
Group B will be treated with Parijatak Gugulu which contains Parijatak and gugulu.
Parijatak Gugulu will be given orally in a dose of 500mg two times a day in vyanodan kaal ,with lukewarm water in 25-65year age group which includes followup on 7th, 14th, 21st ,28th day |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients showing classical symptoms and sign of Gridhrasi that is Padashoola (pain)
,Katishoola (pain),Stambha (stiffness) ,Toda (pricking sensation) ,Spandan (twitching) , Dehasya –Api-Pravakrata (Gait),Aruchi (Anorexia),Tandra (Drowsiness),Gaurav (Heaviness) as
described in ayurvedic samhitas in 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 25-65 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.
11. High risk (above 65 years age, known cases of HTN, DM,COPD)
comorbid patients suspected for covid 19. Suspected covid 19
patient having symptoms as per ICMR guidelines. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare efficacy of krushna churna at vynodan kal with
gomutra10ml & eranda tail 5 ml For 1month & parijatak gugulu 500 mg tab
at vyonodan kal with koshna jal for 1 month in the management of
Gridhrasi |
One month with follow up on 7th 14th 21st and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare and study the efficacy of krushna churna.
2. To compare and study the efficacy of Parijatak Gugulu.
3. To study adverse effect if any |
One month with follow up on 7th 14th 21st and 28th day |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
26/06/2021 |
| 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
|
Note yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Gridhrasi is one of the Vataj Nanatmaj vikar. The location of vayu being kati pradesh , the main concern is the function of locomotion. Being epitome of all the bodily functions , it has the privilege of generating the highest number of diseases described as vataj nanatmaja vikara. Gridhrasi is one of the nanatamaj vikara of vata dosha affecting it’s main sthan that is kati pradesh according to charak samhita. The character of gridhrasi resembles with sciatica I.e radiating pain along the course and distribution of sciatica nerve that is in buttock to outer border of foot. The effectiveness of krushna churna with gomutra and erand tail in gridhrasi is mentioned in bhaisjaya ratnavali 26/40. |