| CTRI Number |
CTRI/2024/09/073353 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on Acupuncture needling in sciatica |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of Acupuncture needling over marma points in Gridhrasi |
| 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 AKSHITHA Y |
| Designation |
PG Scholar |
| Affiliation |
Muniyal institute of ayurveda medical science,Manipal |
| Address |
Outpatient department of Shalya Tantra, room no 9, First floor, Muniyal institute of ayurveda medical sciences, Shivalli industrial area, Manipal Udupi -576104
Udupi
KARNATAKA
576104
India |
| Phone |
8548937383 |
| Fax |
|
| Email |
akshithay123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gururaja D |
| Designation |
Professor and Head of the depaetment |
| Affiliation |
Muniyal institute of ayurveda medical science,Manipal |
| Address |
Outpatient department of Shalya Tantra, room no 9, First floor,Muniyal institute of ayurveda medical sciences, Shivalli industrial area, Manipal Udupi -576104
Udupi
KARNATAKA
576104
India |
| Phone |
8762822790 |
| Fax |
|
| Email |
gurushalya@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR AKSHITHA Y |
| Designation |
PG Scholar |
| Affiliation |
Muniyal institute of ayurveda medical science,Manipal |
| Address |
Outpatient department of Shalya Tantra, room no 9, First floor, Muniyal institute of ayurveda medical sciences, Shivalli industrial area, Manipal Udupi -576104
Udupi
KARNATAKA
576104
India |
| Phone |
8548937404 |
| Fax |
|
| Email |
akshithay123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Muniyal institute of ayurveda medical sciences,Manipal |
|
|
Primary Sponsor
|
| Name |
Muniyal institute of ayurveda medical sciences, Manipal |
| Address |
Muniyal institute of ayurveda medical sciences,Shivalli industrial area,Manipal udupi -576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 AKSHITHA Y |
Muniyal institute of ayurveda medical sciences,Manipal |
Outpatient department of Shalya Tantra, Room no 9, First floor,Muniyal institute of ayurveda medical sciences, Manipal 576104
Udupi
KARNATAKA |
8548937404
akshithay123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muniyal institute of ayurveda institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G544||Lumbosacral root disorders, not elsewhere classified. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vedhana-karma, वेधन-करà¥à¤® | (Procedure Reference: Sushrutha samhitha,Chikitsa sthana 5th chapter, Procedure details: In prone position acupuncture needles are used, inserted and stimulation done over marma points for the duration of one and half minute each. And no particular medicines are using during the trial) for 7 days and follow up will be done 0n 15 th day))
| | 2 | Comparator Arm | Procedure | - | marmacikitsA, मरà¥à¤®à¤šà¤¿à¤•à¤¿à¤¤à¥à¤¸à¤¾ | (Procedure Reference: Sushrutha samhitha,Chikitsa sthana, Procedure details: In prone position,Marma points located on low back region and lower limb are selected for marma chikitsa and manipulation done by using pulp and fingers of hand depending on marma points over the duration of 20 minutes.And no medications are used during the trial for 7 days and the follow-up will be done 15th day))
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with classical signs and symptoms of Gridhrasi.
2. Patient aged 30-60 years of age will be included.
3. Patients belongs to any gender will be included.
4. Persons willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from uncontrolled systemic disorders which worsen the conditions ( eg: DM, HTN)
2.Any congenital anomalies of spine, fracture of spine, neoplastic condition of spine, Tuberculosis of spine, Cauda equina syndrome.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain and stiffness will be assessed |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Minimization of radiating pain, stiffness,tenderness & improve the quality of life |
7 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/09/2024 |
| 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="4"
Days="20" |
|
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
|
First line of management of Marma Abhigata is to protect or correct the Marma and bring the flow of Prana to normalcy which is called as “Marma Chikitsa5. This can be done by externally manipulating or stimulating the Marma points. Mardana and Bandhana are told in the management of Snayu and Sandhigata Vata. Siddha system of medicine gives detailed description about Marma Chikitsa and manipulation method over these points. Varma points according to Siddha are similar to Marma points explained in Ayurveda. Touching the Marma points changes the biochemistry of body and can unfold radical and chemical change. Stimulation of these inner pharmacy pathways signals the body to produce certain neurochemicals that heals the body and mind. Acupuncture, the Chinese system of medicine explains about the stimulation of certain pressure points for the management of pain and certain neurological conditions. Pressure points and the Marma points are analogous in some aspects. Hence stimulation can be done over these Marma points by Acupuncture. As the diameter of the needle is small with high density it does only the stimulation of Marma without harming the Marma points Therapeutic benefits of the Marma points needs to be elaborated by adopting the manipulating techniques of Siddha system of medicine and stimulation techniques of Chinese system of medicine and applying it on Marma points explained in Ayurveda. In this study 40 subjects will be selected on the basis of exclusion, inclusion and diagnostic criteria, in which 20 subjects will be subjected for acupuncture needling for 7 days (Interventional group) and 20 subjects will be subjected for marma chikitsa (Control group). Treatment duration for both groups are 7 days and the follow up will be done on 15th day of trial. Assessment will be doing on every 7 days during the entire study period (1st day BT, 7th ,15th day of treatment), according to the subjective and objective criteria where they will be assigned with scores (absent/mild/moderate/severe) and assessed for the improvement. Such collected data will be tabulated and analyzed using SPSS (Statistical package forsocial sciences) version 20 by using appropriate statistical test |