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CTRI Number  CTRI/2024/07/070564 [Registered on: 13/07/2024] Trial Registered Prospectively
Last Modified On: 12/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [EFFECT OF AYURVEDA PROCEDURE i.e. MARMATHERAPY]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The study to see the effect of Marmatherapy in lowback pain which occurs due to lumbar disc prolapse.  
Scientific Title of Study   The open controlled clinical study to evaluate the effect of 10 days Marmatherapy on pain and mobility with special reference to Lumbar disc prolapse. 
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 MADHURI VITTHALRAO BHANDARE 
Designation  ASSOCIATE PROFESSOR 
Affiliation  M A Podar Hospital worli Mumbai 
Address  Dr Madhuri Bhandare Associate professor Shalyatantra department R A Podar Medical College Worli MUMBAI
Dr Madhuri Bhandare Associate professor and unit incharge Shalyatantra OPD no 10 M A Podar hospital Worli MUMBAI 400018
Mumbai
MAHARASHTRA
400018
India 
Phone  9960108635  
Fax  022-24936881  
Email  bhandare_madhuri@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  DR Yunus Gufar Solanki  
Designation  PROFESSOR 
Affiliation  M.A.Podar hospital worli mumbai  
Address  Dr Yunus Gufar Solanki Professor Shalyatantra department R A Podar Medical College Ayu Worli MUMBAI 400018
Dr Yunus Gufar Solanki Professor Shalyatantra department R A Podar Medical College Ayu Worli MUMBAI 400018
Mumbai
MAHARASHTRA
400018
India 
Phone  9028111243  
Fax  022-24936881  
Email  solankiyunus14@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR YUNUS GAFAR SOLANKI 
Designation  PROFESSOR 
Affiliation  M A Podar Hospital,worli Mumbai 
Address  Dr Yunus Gufar Solanki Professor Shalyatantra department R A Podar Medical College Ayu Worli MUMBAI 400018
Dr Yunus Gufar Solanki shalyatantra opd no 10 M A podar hospital worli mumbai 400018
Mumbai
MAHARASHTRA
400018
India 
Phone  9960108635  
Fax  022-24936881  
Email  solankiyunus14@gmail.com  
 
Source of Monetary or Material Support  
R.A.Podar Medical COllege ( Ayu) worli mumbaimand the affileted hospital i.e.M.A.Podar hospital worli mumbai 400018 
 
Primary Sponsor  
Name  DR MADHURI BHANDARE 
Address  Dr Madhuri Bhandare Associate professor Shalyatantra department R A Podar Medical College Ayu Worli MUMBAI 400018 
Type of Sponsor  Other [PhD research] 
 
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 
DRMADHURI VITTHALRAO BHANDARE  M A PODAR HOSPITAL MUMBAI  Shalyatantra opd no 10 ground floor M A Podarhospital Worli MUMBAI 400018
Mumbai
MAHARASHTRA 		 9960108635
022-24936881
bhandare_madhuri@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
R.A.Podar medical college ayu worli mumbai institutional ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M498||Spondylopathy in diseases classified elsewhere. Ayurveda Condition: VATAVYADHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Charaksamhita Vimansthana 9/10, Procedure details: Firstly Marmas selected for Marma therapy will be marked with the marker. For Mardan of Marma points Vimplapana method will be used which is indicated in the inflammation which is firm and having mild pain. In Vimplapana Mardan will be done with the help of thumb and palm Time peroid of Mardan (pressure) – 1to 2 seconds for each Marma pointFrequency – 15 to 18 times each Marma point Daily – once Duration – 10 days Follow up : on 1st ,3rd ,8th and 15th Day and 30th day.)
2Comparator Arm (Non Ayurveda)-Tab Diclofenac potassium 50mg and Metaxalone (400 mg) Tab Diclofenac potassium 50 mg and Metaxalone 400mg Twice daily for 10 days after food
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Clinically diagnosed patients of lumbar disc prolapse and confirmed by x-ray (lumbosacral spine AP & Lat view) and MRI spine
2.Age group between 25yrs to 45 yrs
3.Lumbar disc prolapse of L4-L5
4.Chronic Lumbar disc prolapse i.e. more than 3 weeks
5.Male and female
6.Controlled DM &HTN patients
 
 
ExclusionCriteria 
Details  1.Pregnant female
2.Paraplegia due to lumbar disc prolapse
3.Vertebral fracture, Potts spine
4.Kyphosis & Scoliosis
5.Rheumatoid arthritis, Spondyolisthesis, Ankylosing spondylitis patients
6. Benign & malignant tumors of vertebral column & spine
7. Metastatic deposits at spine
8. Metabolic disorders like Osteoporosis & Osteomalacia
9. HIV Positive & HbsAg positive patients

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Reduction in pain of lower back and legs.
2.Improvement in movements of lower back and legs. 		 10 Days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Forming of standard operating procedures of Marma Therapy in individuals with lumbar disc prolapse.

2. Studying the effect of Marma Therapy on selected Marma points in individuals with lumbar disc prolapse. 		 36 Months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   14/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
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   Patients of lumbar disc prolapse at L-4 and L-5 are selected for the trial. Selection of patients will be done after the clinical examination and radiological examination of patient i.e. MRI spine. Allocation of patients in each group will be done by using lottery method. Marma therapy treatment will be given to 40 patients of experimental group for 10 days. 40 Patients in control group will be treated with Tab. doclofenac pottasium 50 mg with metaxalone 400 mg twice daily for 10 days. Evaluation of patient will be done before starting the treatment and after completion of treatment. Low back pain and leg pain will be measured with the help of visual analogous scale and improvement of mobility of spine will be assessed by measuring the angle of spine of forward flexion, side flexion and spine rotation with goniometry. Observations will be taken at 0 1 3 8 15 and 30th day .Treatment of patient will be withdrawn if patient develops any complications and who is irregular in follow up and compliance. All collected data will be assessed finally and will be analysed by unpaired t-test for evaluation of pain and spine mobility before and after treatment in both group and  paired t -test will be apply  to compare the results between control and experimental group. Conclusion will be drawn on the basis of findings of results. 
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