| CTRI Number |
CTRI/2024/08/072830 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Osteoarthritis of Knee(janu sandhigatavata) by Marma chiktisa and Agnikarma |
|
Scientific Title of Study
|
Clinical comparative study to evaluate the potential of Marma Chikitsa and Agnikarma with Suvarna Shalaka as an intervention in the management of Janusandhigata vata w.s.r to Osteoarthritis of Knee |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anita lalwani |
| Designation |
(PhD SCHOLAR) |
| Affiliation |
DSRRAU, karwar Jodhpur |
| Address |
OPD room no. 3 Shalya tantra
Shri Shirdi Sai Baba Ayurveda College And Hospital Kishangarh Renwal, Jaipur
Jaipur
RAJASTHAN
303603
India |
| Phone |
9660726831 |
| Fax |
|
| Email |
dranitalalwani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajesh Gupta |
| Designation |
Professor& HOD SHALYA TANTRA |
| Affiliation |
DSRRAU |
| Address |
DSRRAU, Department of Shalya Tantra Nagaur Road Karwar Jodhpur
Jodhpur
RAJASTHAN
342304
India |
| Phone |
9636520573 |
| Fax |
|
| Email |
guptadrrajeshkumargupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anita Lalwani |
| Designation |
Assistant Professor (PhD SCHOLAR) |
| Affiliation |
DSRRAU, karwar Jodhpur |
| Address |
OPD Room no.3 Shalya tantra
Shri Shirdi Sai Baba Ayurveda College And Hospital Kishangarh Renwal, Jaipur
Jaipur
RAJASTHAN
303603
India |
| Phone |
09660726831 |
| Fax |
|
| Email |
dranitalalwani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sarvepalli Radhakrishnan Rajasthan Ayurveda University karwar jodhpur Rajasthan 342037 |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University |
| Address |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurveda University Nagaur Road Karwar Jodhpur 342304 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrAnita Lalwani |
Shri Shirdi Sai Baba Ayurveda College And Hospital |
OPD No. 3 Shalya Tantra
Shri Shirdi Sai Baba Ayurveda College And Hospital KISHANGARH RENWAL JAIPUR 303603
Jaipur
RAJASTHAN |
9660726831
dranitalalwani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee ,PGIA, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, (2) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta Samhita Sutra Sthan chapter no. 12, Procedure details: ➢ Shalaka: Suvarna (Gold) Shalaka -14 carat
➢ Dimensions - 7cm long 2mm thick 4 mm end (tip of shalaka)
➢ Triphala Kwatha (decoction): It was used for the cleaning of local part
before Agnikarma.
➢ Ghritakumari (Aloe barbadensis Miller. leaf): It was used as soothing effect
after Agnikarma (dressing purpose))
| | 2 | Intervention Arm | Procedure | - | Marmacikitsa, मरà¥à¤®à¤šà¤¿à¤•à¤¿à¤¤à¥à¤¸à¤¾ | (Procedure Reference: Sushruta Samhita Sharir Sthan Chapter no. 6, Procedure details: KÄla: Thrice a day.
➢ Marma points – janu marma, indravasti marma,Gulpha marma & kshipra marma
➢ Duration of therapy: 15-18times pressure is given in one sitting on each Marma (as same
asrhythm of our respiration/ with chanting of OMM /0.8 sec) thrice a day for 30 days
and follow up of for 2 months once in a month. Mild to moderate pressure is given,
depending upon the tolerance capacity of person up to limit of absence of any kind of facial
discomfort/ pain.
➢ Follow up: Day 0, Day 15, Day 30, Day 45, &Day 60.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 40-70 years, irrespective of sex, religion and socio-economic status.
Patients having clinical features of Sandhigata Vata as described in ayurvedic
scriptures, as well as clinical features of Osteoarthritis of knee
Patients fit to undergo Marma therapy and Agnikarma and willing to sign
the informed consent.
|
|
| ExclusionCriteria |
| Details |
Age <40years and >70 years
Patients with grade 4 x ray findings.
Subjects suffering from any other type of arthritis like rheumatoid Arthritis,
psoriatic arthritis. Infective arthritis, gout, ankylosing spondylitis
Subjects with any other serious systemic disorder, which may interference with the
treatment
Traumatic causes like fracture.
Pregnancy and lactation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Efficacy of Marma chikitsa
2. Relief in symptoms
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Acceptability/ Tolerance of treatment
2.Improved quality of life |
30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/09/2024 |
| 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="0"
Months="6"
Days="0" |
|
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
|
Osteoarthritis (OA) is one of the most common and disabling musculoskeletal
disorder, which is extremely common in the elderly population. Osteoarthritis is a long-term
chronic disease that involves the deterioration of cartilage in joints (which may be knee, hip,
feet, hand, shoulder or spine), with the result that the bones start rubbing together, and cause
pain, stiffness, and restriction of movement. This study is to evaluate the effect of Marma therapy (study group) in the management
of janu sandhigata vata w.s.r to osteoarthritis of knee and also to compare the effect of Marma therapy and Agnikarma with Suvarna shalaka in
the management of janu sandhigata vata w.s.r to osteoarthritis of knee. |