CTRI/2025/01/079704 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On:
25/01/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda Other (Specify) [marma chikitsa]
Study Design
Other
Public Title of Study
Effect of Ayurveda treatment in lumbar canal stenosis with neurogenic claudication
Scientific Title of Study
Comparative study on the management of lumbar spinal stenosis with neurogenic claudication between modern medicine and ayurveda treatment including marma chikitsa based on kevala vataja and urusthambha samprapthies A black box clinical trial
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Neethu Vikram MB
Designation
First Year PhD Scholar
Affiliation
ALL INDIA INSTITUTE OF AYURVEDA
Address
Room no 506,5 th floor,Dept of Shalyatantra
All India Institute Of Ayurveda,
Goutampuri, Sarita Vihar,Mathura Road 110076
South DELHI 110076 India
Phone
9400527309
Fax
Email
neethuvikrammb@gmail.com
Details of Contact Person Scientific Query
Name
Prof.Dr.Yogesh Badwe
Designation
Professor and HOD,Dept Of Shalya Tantra
Affiliation
All India Institute Of Ayurveda
Address
Room no-504,5 th floor,Dept of Shalya tantra,All India Institute Of Ayurveda,
Goutampuri, Saritha Vihar, Matura Road 110076
South DELHI 110076 India
Phone
9011060498
Fax
Email
dryogesh.badwe@gmail.com
Details of Contact Person Public Query
Name
Neethu Vikram MB
Designation
First Year PhD Scholar
Affiliation
All India Institute Of Ayurveda
Address
Room no-504,5 th floor,Dept of Shalya tantraAll India Institute Of Ayurveda,
Goutampuri, Saritha Vihar,Matura Road 110076
South DELHI 110076 India
Phone
9400527309
Fax
Email
neethuvikrammb@gmail.com
Source of Monetary or Material Support
All India Institute of Ayurveda, New Delhi,India,110076
Primary Sponsor
Name
All India Institute Of Ayurveda
Address
All India Institute Of Ayurveda,
Goutampuri, Sarita Vihar,Matura Road 110076
Type of Sponsor
Research institution and hospital
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Neethu Vikram
All India Institute of Ayurveda, New Delhi
Room no 506,5 th floor,Dept of Salya tantra
Goutampuri, Saritha Vihar, Matura Road, 110076 South DELHI
09400527309
neethuvikrammb@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional ethics committee,All India Institute of Ayurveda
(Procedure Reference: Charak Samhita, Procedure details: Kolakulatthadi churma 50 gm pottali will be made & after heating the pottali it will be applied of over affected area for 45 min.) (1) Medicine Name: kolakulatthadi churna, Reference: Charak samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 50(g), Frequency: od, Duration: 7 Days
9
Intervention Arm
Procedure
-
yoga-bastiH, योग-बस्तिः
(Procedure Reference: Charak Samhita, Procedure details: Anuvasana basti- Dhanvantar Taila- 60 mL Niruha Basti- Madhutailik basti 900 mL total duration 8 days.) (1) Medicine Name: dhanvantar taila, Reference: ashtang hridayam, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 8 Days
10
Comparator Arm
Procedure
-
udvartanam, उद्वर्तनम्
(Procedure Reference: Ashtang Hridaya, Procedure details: Kolakulatthadi Churna with sufficient qty will be taken & dry churna will be rubbed all over the body for 45 min) (1) Medicine Name: Kolakulatthadi churna, Reference: charaka samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 100(g), Frequency: od, Duration: 8 Days
11
Comparator Arm
Procedure
-
sa~gkarasvedaH, संकरस्वेदः
(Procedure Reference: charaka samhita, Procedure details: kolakulatthadi churna 50 gm will be made into pottali & heated pottali will be applied over affected area for 45 min) (1) Medicine Name: kolakulatthadi churna, Reference: charak samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 50(g), Frequency: od, Duration: 7 Days
patients suffering from lumbar canal stenosis causing neurogenic claudication in the age group of 40 to 70 years, as per ICD 10 classification lumbar canal stenosis causing neurogenic claudication belongs to cluster code NO M48.062,X ray CT MRI diagnosed cases of lumbar spinal stenosis causing neurogenic claudication,patients fulfilling signs and symptoms of either kevala vatavyadhi or urustambha lakshanas presenting with lumbar spinal stenosis causing NC
To compare the treatment outcome in the management of lumbar spinal stenosis with neurogenic claudication between kevala vataja and urustambha treatment protocol along with marma chikitsa and non surgical treatment in modern medicine
Two years
Secondary Outcome
Outcome
TimePoints
to evaluate the efficacy of marma chikitsa in lumbar spinal stenosis with neurogenic claudication
2 years
Target Sample Size
Total Sample Size="45" Sample Size from India="45" 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 2
Date of First Enrollment (India)
15/02/2025
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="2" 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
Spinal pain remains the leading cause of global disability.Lumbar spinal stenosis (LSS) is a frequent cause of chronic low back and leg pain which is associated with significant disability and functional limitations.Symptomatic LSS typically described as neurogenic claudication (NC) characterised by unilateral or bilateral buttock,thigh or calf symptoms precipitated by prolonged standing or walking and relieved by sitting,lumbar flexion and lying down.The researchers of the present project find a lot of similarities in LSS causing NC and Urustambha as described by Acharya Charaka in chapter 27 chikitsa sthana sloga number 13,15,17 and 18.However till date there is no clear understanding of concept of Urustambha and its clinical application in the contemperory Ayurveda literature.To the best of our knowledge , the present study is the first to draw a parallel between Urustambha and LSS causing NC. This study is also the first of its kind where objectivization and stratification of Urustambha and LSS causing NC is proposed to be done on X ray,MRI and CT scan.According to samprapthi pathways 3 groups are considered.Group A – Kevala vataja ,group B-Urustambha group and group C with modern intervention. Sample size is considered to be 45 with 15 in each group as far as the paucity of Urustambha is considered.