| CTRI Number |
CTRI/2025/07/091228 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study effectiveness between Ayurvedic medicine Bharangimool churnavati and Nirgundi ghanavati in the management of Gridhrasi (Sciatica) |
|
Scientific Title of Study
|
A randomized comparative clinical trial to evaluate the efficacy of Bharangimool churnavati and Nirgundi ghanavati 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 Rutuja Chandrakant Solunke |
| Designation |
PG Scholar |
| Affiliation |
PDEAs college of ayurved and Research centre Nigdi pune 411044 |
| Address |
Third floor,Kayachikitsa DepartmentPDEAs College of Ayurveda and Research centre, Nigdi pradhikaran Pune, 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
7057451220 |
| Fax |
|
| Email |
rutujasolunke1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Girish Taksale |
| Designation |
Associate professor |
| Affiliation |
PDEAs college of ayurved and Research centre,Nigdi,pune 411044 |
| Address |
Third floor,Kayachikitsa DepartmentPDEAs College of Ayurveda and Research centre, Nigdi pradhikaran, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9011061293 |
| Fax |
|
| Email |
taksaleabhishek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rutuja Chandrakant Solunke |
| Designation |
PG Scholar |
| Affiliation |
PDEAs college of ayurved and Research centre Nigdi pune 411044 |
| Address |
Third floor,Kayachikitsa Department,PDEAs College of Ayurveda and Research centre, Nigdi pradhikaran Pune,India,maharashtra 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
7057451220 |
| Fax |
|
| Email |
rutujasolunke1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurveda and Research centre Nigdi, Pune, Maharashtra,India 411044 |
|
|
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 |
| Dr Rutuja chandrakant Solunke |
Ayurved Rugnalaya And Snowbell Multi-Speciality Hospital ,Pune |
Ayurved Rugnalaya And Snowbell Multi-Speciality Hospital ,Sector no.27,Kayachikitsa Department,Ground floor, OPD NO 117 ,Nigdi pradhikaran,Pune 411044
Pune
MAHARASHTRA |
7057451220
rutujasolunke1999@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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bharangimool churnavati , Reference: Gadanigrah,kayachikitsa khand volume 2,vaatrogadhikar adhyay 19 page no 521 ,19/225, 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: Bharangimool churnavati classical reference given in gadanigrah kayachikitsa khand volume no.2 vaatrogadhikar adhyay 19/225 page no.521 | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nirgundi Ghanavati , Reference: sharangdhar samhita madhyaym khand,adhyay 2,shlok no.84, 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: Nirgundi ghanavati classical reference given in sharangdhar samhita madhyam khand adhyay 2 shlok no.84 |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.SLR test positive patient with the help of goniometer.
2.Patients in the age group of 25-60 years ,irrespective of religion,caste,gender and socioeconomic status.
3.Patient with classical signs of Gridhrasi jaanujanghapadam kramat and sakthikshepnigrahanat should be there
4.Radiating pain from kati pradesh (lower back) to paad ( foot )should be there . Radiating pain along the course and distribution of sciatic nerve
5.Associated symptoms are- Patients having two or more following symptoms - katishool (lower back pain) spand (throbbing /pulsating) toda (pricking sensation ) aruchi ( anorexia) Gourav(heaviness)
paadshool (leg pain ) |
|
| ExclusionCriteria |
| Details |
1.Patients having congenital anomalies with lumbosacral spine kyphosis, scoliosis, lordosis.
2.Known case of Spondylolisthesis, sacroiliac arthritis.
3.Known case of uncontrolled diabetes mellitus , deep vein thrombosis.
4.Pregnant and lactating mothers.
5.Patients with paraplegia of lower limb.
6.Fracture of spinal bones or in lower extremity bones.
7.Known case of Infective disorders –tuberculosis of Spine, osteomyelitis of spinal bone.
8.Patients with deep wounds penetrating till sciatic nerve.
9.Patients having any major chronic/acute systemic /surgical pathology like malignancies.
10.Patients having allergy to any content of drugs.
|
|
|
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 |
1.To compare the efficacy Of Bharangimool churnavati and Nirgundi Ghanvati In relieving pain given for 21 days in management of Gridhrasi
|
21 Days with follow up on 8th,15th,22nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the efficacy Of Bharangimool churnavati and Nirgundi Ghanvati for relieving other symptoms given for 21 days in management of Gridhrasi .
2.To observe and compare the adverse effects in two groups within 21 days
|
21 Days with follow up on 8th,15th,22nd day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
02/08/2025 |
| 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)
|
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
|
- In the present era, lifestyle trends are shifting away from healthy living, leading to an increase in various health issue, One such condition is Gridhrasi, is a nanatmaj vata vyadhi Lower back pain is an incredibly common musculoskeletal disorder that affects leg movement. Among patients experiencing this condition, approximately 40% suffer from radicular pain, which can be classified as part of the sciatica syndrome. Gridhrasi , which manifest as pain starting from the lower back (kati) and radiating down to the buttocks, thighs (uru) Knees ( Janu), Calves and feet.
- This pain pattern closely resembles sciatica, a debilitating condition where hip pain extends downs the leg and foot due to compression of sciatic nerve.
- In modern medicine Gridhrasi correlated with sciatica
- In modern medicine sciatica pain is managed by using anti- inflammatory, muscle relaxants, physiotherapy and even the surgical intervention but the chances of re-occurrence as well.
- Ayurveda provides several effective options in the management of Gridhrasi.
- Vataj Gridhrasi – This type is characterized by stiffne ( Stambha), Pricking pain (toda), twitching or trembling sensation( Spandana) and severe pain (Ruk) Orginating from the gluteal region (sphik pradesha) the pain radiates down to various body parts, including the pelvis ( kati), back ( Prushta) thigh( Uru) Knee (janu), foot (paada)
- Vata- Kaphaj Gridhrasi – in addition to the symptoms mentioned above this type presents with lethargy (tandra), Heaviness ( Gaurav) and loss of appetite ( Aruchi)
Study Rationale: - Although lots of work have been done in the management of Gridhrasi , still alternative medicines are required
- Bharangimool churnavati is easily available and cost effective, In modern medicine painkillers give symptomatic relief only.
- No other work has been done on the effect Bharangimool churnavati in the management of Gridhrasi, hence this formulation has been selected for the study .
- In the treatment of Gridhrasi drug of choice should have Vatashamak, kaphashamak Bharangi have both vatshamak and kaphashamak properties.
- Bharangimool churnavati is mentioned in Gadanigrah having all properties may reverse the pathogenesis of Gridhrasi.
- A rational of the study To compare the efficacy Of Bharangimool churnavati with Nirgundi Ghanvati for relieving the symptoms of Gridhrasi.
|