| CTRI Number |
CTRI/2024/11/077437 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study effectivness between Shigru ghanvati and Nirgundi ghanvati in the management of Gridhrasi in the age group 25 to 65 years |
|
Scientific Title of Study
|
A randomised controlled clinical trial to evaluate effectivness of Shigru ghanvati in the management of Gridhrasi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Snehal Balkrishna Kuber |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurveda and Research centre Nigdi,Pune. |
| Address |
PDEAs College of Ayurveda and Research centre,third floor kayachikitsa Department Nigdi pradhikaran,Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9405464995 |
| Fax |
|
| Email |
snehal.kuber262@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Tarachand Khobragade |
| Designation |
HOD kayachikitsa Department |
| Affiliation |
PDEAs College of Ayurveda and Research centre Nigdi,Pune. |
| Address |
PDEAs College of Ayurveda and Research centre, 3 rd floor, kayachikitsa Department,Nigdi Pradhikaran, Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
8378929859 |
| Fax |
|
| Email |
khobragaderupali19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal Balkrishna Kuber |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurveda and Research centre Nigdi,Pune. |
| Address |
PDEAs College of Ayurveda and Research centre,third floor kayachikitsa Department Nigdi pradhikaran,Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9405464995 |
| Fax |
|
| Email |
snehal.kuber262@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS college of Ayurveda and Research centre pradhikaran nigdi pune. |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurveda and Research centre Nigdi Pradhikaran, Pune. |
| Address |
PDEAs College of Ayurveda and Research centre Nigdi Pradhikaran,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 |
| DrSnehal Balkrishna Kuber |
Ayurved Rugnalaya and Multi-speciality Hospital,Nigdi Pradhikaran,pune. |
Ayurved Rugnalaya and Sterling Multi-speciality Hospital Sector27, Kayachikitsa Department,ground floor OPD no 117 Nigdi Pradhikaran Pune.411044
Pune
MAHARASHTRA |
9405464995
snehal.kuber262@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,college of Ayurveda and Research centre Nigdi,Pune. |
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: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nirgundi ghanvati , Reference: Bhavprakrash , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shigru ghanvati , Reference: Bhavprakrash , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nirgundi ghanvati , Reference: Bhavprakrash , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having classical sign and symptoms of Gridhrasi.cardinal Symptoms kati te paad sanachari vedana should be there
2.katishool ,padshool
3.Radiating pain along the course and distribution of sciatic nerve that is buttock to outer border of the foot.
Associated Symptoms Stambh (stiffness),toda,Spanda(twiching),arochak,gourav.
4.SLR test Positive patients with the help of Goniometer.
5. patients between the age of 25 to 65 years. |
|
| ExclusionCriteria |
| Details |
1.patient having congenital anomalies with limbo sacral spine such as kyphosis and scoliosis.
2. History of fracture of spinal bones,lower extremity bone any spinal surgery,neurological disorders.
3. History of infective disorder -T.B. of spine, osteomyelitis of spine.
4.patients with paraplegia of lower limb
5. Patients having any major chronic or acute systemic/ surgical pathology like malignancies and RA.
6.patients with deep wound penetrating till sciatic nerve.
7.patients with dislocation of hip joint amputation above knee joint.
8. Patients having symptoms caused by prolonged pressure on hip like comatose patients.
9. pregnant and lactating mothers. |
|
|
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 effectivness of Shigru ghanvati 500mg at vyanodan kal with koshana jal for 21 days and Nirgundi ghanvati 500 mg vyanodan kal with koshna jal for 21 days in the management of Gridhrasi. |
21 days with follow up 7th 14th,21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To obeserve the adverse effect,if any |
21 days with follow up 7th,14th,21st day. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
05/12/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gridhrasi is one of the vataj Nanatmaj vikar.The location of vayu being in kati Pradesh and main concern is function of locomotion being essense of all body functions.In gridhrasi pain start from sphik Pradesh and radiates insidiously towards waist prishtha then uru janu and pada. Gridhrasi can be correlated with sciatica.I.e.radiating pain along with the course and distribution of sciatic nerve that is buttock to outer border of foot. Gridhrasi is one of the Nanatmaj vikar of vata dosha affecting its main sthan that is katipradesh according to charak samhita. Shigru mentioned in Bhavprakash having all properties may reverse pathogenesis of gridhrasi. |