| CTRI Number |
CTRI/2025/02/081480 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison on effectiveness of chinchapinda sweda and patrapinda sweda in Gridrasi - Sciatica |
|
Scientific Title of Study
|
Efficacy of Chinchapinda sweda in comparison to Patrapinda sweda in Gridhrasi - Sciatica -A Randomized Clinical Trail |
| 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 Ramanagouda |
| Designation |
2nd year PG scholar |
| Affiliation |
Department of Panchakarma Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital |
| Address |
Department of Panchakarma Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital OPD 14 and 26
Bangalore KARNATAKA 560074 India |
| Phone |
9110281577 |
| Fax |
|
| Email |
ramanagowdab.hosmani@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prashanth kumar |
| Designation |
Associate professor |
| Affiliation |
Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital |
| Address |
Department of Panchakarma Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital OPD 14
Bangalore KARNATAKA 560074 India |
| Phone |
9844708874 |
| Fax |
|
| Email |
drpknrao@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prashanth kumar |
| Designation |
Associate professor |
| Affiliation |
Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital |
| Address |
Department of Panchakarma Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital OPD 14
Bangalore KARNATAKA 560074 India |
| Phone |
9844708874 |
| Fax |
|
| Email |
drpknrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital anchepalya kumbalagodu post bangalore 560074 karnataka india |
|
|
Primary Sponsor
|
| Name |
Dr Ramanagouda |
| Address |
Department of Panchakarma Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital OPD 14 and 26 Anchepalya Bangalore karnataka 560074 |
| 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 Ramanagouda |
Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital |
Department of Panchakarma OPD 14 and OPD 26 Bangalore KARNATAKA |
9110281577
ramanagowdab.hosmani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:7||Osteopathic. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | svedanam, स्वेदनम् | (Procedure Reference: Charaka Sutra Sthana Sweda Adhyaya, Procedure details: Heat herbal Pottali. Then the heat is applied to the patient body for Swedana over the low back & both legs, continued about 45 minutes duration )
| | 2 | Comparator Arm | Procedure | - | svedanam, स्वेदनम् | (Procedure Reference: Charaka Samhita Sutra Sthana Swedana Adhyaya, Procedure details: Heat herbal Pottali. Then the heat is applied to the patient body for Swedana over the low back & both legs, continued about 45 minutes duration)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling the diagnostic criteria of Gridhrasi (Sciatica).
2. Patients of either gender between age group 30-60 years
3. Patients with positive physical signs & special test of Sciatica.
4. Patients who are willing for consent |
|
| ExclusionCriteria |
| Details |
1. Congenital deformities of the spine
2. Malignant conditions of the spine
3. Infective, inflammatory diseases of spine
4. Traumatic conditions of the lumbar spine like Compressive fractures, Quada equina compression
5. AVN head of femur
6.Pregnancy.
7.Any other systemic illness like uncontrolled DM, HTN, which interfering the treatment
7.Post-surgical conditions of lumbar spine
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in the clinical signs & symptoms of Gridhrasi - Sciatica is assessed through Clinical Gradings.
2. Reduction in the Pain is assessed by using VAS scale.
3. Improvement in Objective parameters is assessed by SLR test.
|
0th day - before treatment
10th day - after treatment
20th day - follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the functionality is assessed through Oswestry Disability Index (Questionnaire’s method). |
0th day (before treatment)
10th day (after treatment)
20th day ( follow up) |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
11/03/2025 |
| 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
|
Low
back pain is one of the common conditions of musculoskeletal disorder, affects
people during their productive life. About 40% cases of Low back pain are of
radicular in origin and considered under the Sciatic syndrome. Gridhrasi
is one of the most common disorders of Vata, which closely resembles
with Sciatica, which is characterized by pain or discomfort associated with Sciatic
nerve. The prevalence of Sciatica varies considerably ranging from 13% to 40%, the
corresponding annual incidence of an episode of Sciatica ranges from 1% to 5%.
Contemporary medicine has limitations giving short-term relief in pain or
surgical intervention with less desired effect.
Sciatica
is a debilitating condition characterized by pain and paresthesia with in the
sciatic nerve distribution or associated lumbosacral nerve root that occurs
most often due to herniation of a disc or an overgrowth of bone that puts
pressure on part of the nerve which leads to low back pain that begins with the
lumbosacral region and radiates along with the posterio-lateral aspects of the
thigh.
Gridhrasi
is one among the vataja nanatmaja vyadhi which can manifest as
either Vataja type or Vatakaphaja type and it can
be correlated to the disease Sciatica in contemporary science. The common
symptoms are seen as Kramatah shoola from Sphik, Kati, Prista, Uru,
Janu, Jangha & Pada associated with Stambha, Toda, Muhur spandana
& Sakthikshepa nigraha in Vataja type whereas in Kaphanubandhí
type it is associated with Tandra, Gourava & Aruchi .
Snehana, Swedana and Mrudu Shodhana described as
treatment principle of Vatavyadhi . Pinda
Sweda like Patrapinda or Chinchapinda are types of Swedana which are beneficial
in treating Vataja and Vata-kaphaja vyadhi. Patrapinda Sweda which contains
drugs like Patras of Eranda, Nirgundi etc used in the form of Pottali and acts as Vatahara,
Shoolahara, Stambhahara. Chincha (Ripened fruit pulp) is considered to be vatahara and kaphahara
which can be used in
the form of Pinda sweda may have beneficial effect on vatavyadhi in relieving the
symptoms. Both these therapies are having their own significant actions based
upon the selection of drugs and also mode of usage of therapy. |