| CTRI Number |
CTRI/2024/08/072766 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study To Know The Efficacy Of Katibasti With Agnitila In Gridhrasi (Sciatica) |
|
Scientific Title of Study
|
A Controlled Clinical Study On The Therapeutic Efficacy Of Katibasti With Agnitaila In Gridhrasi (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 |
Dr Allappa Kumbar |
| Designation |
2nd year PG Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital Bengaluru |
| Address |
Department of Panchakarma OPD no 14 and 26 Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital Anchepalya Bengaluru Karnataka 560074 India
Bangalore KARNATAKA 560074 India |
| Phone |
7204742103 |
| Fax |
|
| Email |
draskumbar@sdmayurbangalore.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prashanth Kumar |
| Designation |
Associate Professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
| Address |
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital OPD 14 and 26 Anchepalya Bengaluru
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 Manjunatheshwara Institute of Ayurveda and Hospital |
| Address |
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital OPD 14 and 26 Anchepalya Bengaluru
Bangalore KARNATAKA 560074 India |
| Phone |
9844708874 |
| Fax |
|
| Email |
drpknrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital Anchepalya Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr Allappa Kumbar |
| Address |
Department of Panchakarma OPD no 14 and 26 Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital Anchepalya Bengaluru Karnataka 560074 India |
| 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 Allappa Kumbar |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital Anchepalya Bengaluru Department Of Panchakarma OPD 14 and 26 Bangalore KARNATAKA |
7204742103
draskumbar@sdmayurbangalore.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kaTibastiH, कटिबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: charaka sutrastana 14 chapter, Procedure details: Katibasti with Agnitaila is done for 45 minutes per patient per day) (1) Medicine Name: Agnitaila , Reference: Proprietary , Route: Topical, Dosage Form: Taila, Dose: 300(ml), Frequency: od, Duration: 10 Days | | 2 | Comparator Arm | Procedure | - | kaTibastiH, कटिबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charaka sutrastana 14 chapter, Procedure details: katibasti with Nirgundi taila is done for 45 minutes per patient per day) (1) Medicine Name: Nirgundi taila, Reference: Bhaishajya ratnavali Snehakalpana adhyaya, Route: Topical, Dosage Form: Taila, Dose: 300(ml), Frequency: od, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients fulfilling the diagnostic criteria of Gridhrasi (Sciatica)
2 Age group 30-50 years
3 Patients with positive physical signs / special test of Sciatica
4 Patients who are voluntarily willing to sign consent form
|
|
| ExclusionCriteria |
| Details |
1 Congenital deformities of the lumbar spine
2 Malignant conditions of the lumbar spine
3 Infective, inflammatory diseases of lumbar 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 etc which interfering the treatment
8 Post-surgical conditions of lumbar spine.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the clinical signs and symptoms of Gridhrasi
(Reduction in pain radiating from lower back along the pathway of sciatica nerve till the foot) |
Duration of study 10 days
Follow up 20th day
Total study period 20 days
1st assessment (before treatment)
2nd assessment 10th day(After Treatment)
Follow up 20th day(without assessment)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •Improvement in the functionality is assessed through Oswestry Disability Index (Questionnaire’s method) |
1st assessment (before treatment)
2nd assessment 10th day(After Treatment)
Follow up 20th day
(without assessment)
|
|
|
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)
|
10/09/2024 |
| 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="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 with sciatica is one of the most significant health problems in current-day
practice. It also contributes to social life as well as economic crises in the
form of deterioration in work productivity. Low back pain is the prime factor
for disability & ranks 6th for the overall burden on the world
population. The lifetime incidence of sciatica is reported to be between 10% to
40% and an annual incidence of 1% to 5%. The majority of incidence occurs in
the 4th – 5th decade of the working population .
Gridhrasi is one among the Shoola
pradhana vataja nanatmaja vyadhi & it can be correlated
to the disease Sciatica in contemporary science which can manifest as either Vataja type or Vatakaphaja type. The common symptom 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 Kaphanubandhi type it
is associated with Tandra, Gourava &
Aruchi .
Sciatica is
a debilitating condition 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 to leg with difficulty in walking
& paresthesia that travels along the path of the sciatica nerve. The
management of sciatica includes analgesics, anti-inflammatory drugs, steroid
injections & physiotherapy . Prolonged usage of these may
lead to many adverse effects.
Ayurveda classics explain the treatment for Vatavyadhi in detail in which Snehana, Swedana & Mridu shodhan are the prime
line of treatment for vitiated Vatadosha.
The Chikitsa sutra mentioned for Gridhrasi as Bastikarma, Siravyadha, Agnikarma & Virechana karma are
considered as Vishesha chikitsa .
The proper execution of these treatment principles will help in relieving
the symptoms of the Gridhrasi.
Katibasti is a form of Snehayukta
sweda and also Samshamaneeya
bahirparimarjan chikitsa. The combination of Snehana & Swedana in Katibasti works together in relieving the Shoola, Stambha, etc. so that one can
achieve symptomatic relief by increasing in functional ability of the affected
region .
Agnitaila is a proprietary medicine and consists of
ingredients like Tila, Punnaga, Nirgundi,
Lavanga, Maricha, Lashuna & Sarshapa being Ushnaveerya dravya are having the Vatahara, Shoolahara, Stambhahara
and also Kaphahara in action.
Nirgundi taila consists of ingredients like Nirgundi, Langali & Tila being Ushnaveerya dravya having the Vatahara, Shoolahara, Stambhahara and
also Kaphahara in action.
The Snehayukta sweda in the form of Katibasti may give significant relief in
the treatment of Vatavyadhi. Hence an
attempt is made to see the therapeutic efficacy of Katibasti with Agnitaila
has been taken for the study.
|