| CTRI Number |
CTRI/2025/04/084613 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [procedure] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the efficacy of eranda patra pinda sweda and nirgundi patra pinda sweda in the management of sciatica. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of eranda patra pinda sweda and nirgundi patra pinda sweda in the management of gridrasi with special reference to sciatica |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishna barabhai |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Muniyal Institute Of Ayurveda Medical Science |
| Address |
Outpatient department of panchakarma, Room no.3, Ground floor, Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8073080474 |
| Fax |
|
| Email |
krishnabarabhai2222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudarshan A |
| Designation |
PROFESSOR |
| Affiliation |
Muniyal Institute Of Ayurveda Medical Science |
| Address |
Outpatient department of panchakarma, Room no.3, Ground floor, Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9481227666 |
| Fax |
|
| Email |
drsalevoor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudarshan A |
| Designation |
PROFESSOR |
| Affiliation |
Muniyal Institute Of Ayurveda Medical Science |
| Address |
Outpatient department of panchakarma, Room no.3, Ground floor, Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi
KARNATAKA
576104
India |
| Phone |
9481227666 |
| Fax |
|
| Email |
drsalevoor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Muniyal institute of ayurveda medical sciences ,manipal, 576104,udupi, karnataka, india |
|
|
Primary Sponsor
|
| Name |
Krishna barabhai |
| Address |
Outpatient department of panchakarma, Room no.3, Ground floor, Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi |
| Type of Sponsor |
Other [Self] |
|
|
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 Krishna barabhai |
muniyal institute of ayurveda medical sciences manipal. |
Outpatient department of panchakarma, Room no.3, Ground floor, Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi
Udupi
KARNATAKA |
8073080474
krishnabarabhai2222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| muniyal institute of ayurveda medical science manipal institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | piNDasvedaH, पिण्डस्वेदः | (Procedure Reference: Dwivedi, Lakshmidhar. "Hindi Commentary on Charaka Samhita by Maharishi Agnivesha with Ayurveda Dipika Commentary by Shri Chakrapanidatta." Part 3, Chapter 28, Verse 80 pg 927, Procedure details: Nirgundi patra is cut into small pieces & fried with 200ML of Tila taila in the round bottom vessel. The fried leaves are put in a cotton cloth free ends are folded & tried with a thread thus Pottali is prepared. This pottali is heated in oil and is used for sweda.In the patients suffering from classical signs and symptoms of Gridrasi,abhyanga is given as purvakarma with tila taila for 15 minutes and followed up by nirgundi patra pinda sweda for 30mins below the lumbar region till the foot on the affected side.
)
(1) Medicine Name: Nirgundi, Reference: Dr.Lalkrishnan, arogya raksha kalpa druma,keralas tradition of ayurvedic pediatric care 1st edition choukamba sanskrit series chapter 24 pg 192, Route: Topical, Dosage Form: Not Applicable, Dose: 300(g), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | piNDasvedaH, पिण्डस्वेदः | (Procedure Reference: Dwivedi, Lakshmidhar. "Hindi Commentary on Charaka Samhita by Maharishi Agnivesha with Ayurveda Dipika Commentary by Shri Chakrapanidatta." Part 3, Chapter 28, Verse 80 pg 927, Procedure details: Eranda patra is cut into small pieces & fried with 200ML of Tila taila in the round bottom vessel. The fried leaves are put in a cotton cloth free ends are folded & tried with a thread thus Pottali is prepared. This pottali is heated in oil and is used for sweda.In the patients suffering from classical signs and symptoms of Gridrasi,abhyanga is given as purvakarma with tila taila for 15 minutes and followed up by eranda patra pinda sweda for 30mins below the lumbar region till the foot on the affected side.
)
(1) Medicine Name: Eranda, Reference: Dr.Lalkrishnan, arogya raksha kalpa druma,keralas tradition of ayurvedic pediatric care 1st edition choukamba sanskrit series chapter 24 pg 192, Route: Topical, Dosage Form: Not Applicable, Dose: 300(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are already diagnosed with sciatica.
Patients who have classical signs of gridrasi
Tenderness in the course of sciatic nerve |
|
| ExclusionCriteria |
| Details |
Pre diagnosed cases of
1. Malignant conditions of spine
2. TB spine, Congenital Spinal deformities,
3. Spinal canal stenosis.
4. 3rd and 4th degree Disc prolapse.
5. Disc rupture
6. Traumatic fractures of spine.
7. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to reduce radiating pain and stiffness |
on 0th, 8th and 14th day pain and stiffness will be assessed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| increase range of movements |
on 0th, 8th & 14th day range of movements will be assessed |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Gridrasi is one such disease where lower extremities are greatly affected and the pain associated with it is almost intolerable. The disease GRIDRASI is so named because the gait of the person suffering from it similar to that of a GRIDRA PAKSHI. The pain starts from Spik and is then radiated to kati, prustwa.janu jangha and Pada
In allopathic system of medicine, SCIATICA may be the most possible correlation to gridrasi as there is resemblance in the causes signs and symptoms. Sciatica pertains to symptoms originating from sciatic nerve,a significant nerve comprised of many smaller nerves these nerves traverse through the buttock region before extending down the posterior aspect of each leg.
The general line of treatment for vata dosha is snehana and swedana and basti hence swedana can also be considered for gridrasi". As both ERANDA AND NIRGUNDI are used as drugs for allevation of vata as well as for swedana 15 16 17 18 19 hence a study is been made to compare the effectiveness of eranda patra pinda sweda and nirgundi patra pinda sweda in the pain management of gridrasi. |
