CTRI/2024/10/074816 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On:
11/09/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Comparisson of Marma stimulation and selected ayurvedic treatments in cervical radiculopathy.
Scientific Title of Study
A clinical study to evaluate the effect of stimulation of selected Marma points in comparison with rooksha sweda and abhyanga-ushmasweda in the management
of pain in cervical radiculopathy.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Sourav KT
Designation
PG scholar
Affiliation
Government ayurveda college, trivandrum, kerala
Address
Department of shalyatantra,3rd floor, room - sushruta hall, op room 3 Government ayurveda medical college and hospital, NH 66 Vanchiyoor, trivandrum, kerala
Thiruvananthapuram KERALA 695001 India
Phone
9995671529
Fax
Email
dr.sourav.kt@gmail.com
Details of Contact Person Scientific Query
Name
Sourav KT
Designation
PG scholar
Affiliation
Government ayurveda college, trivandrum, kerala
Address
Department of shalyatantra 3rd floor room - sushruta hall, op room 3 Government ayurveda medical college and hospital, NH 66 Vanchiyoor, trivandrum, kerala
Thiruvananthapuram KERALA 695001 India
Phone
9995671529
Fax
Email
dr.sourav.kt@gmail.com
Details of Contact Person Public Query
Name
Dr Remya V R
Designation
Assistant professor
Affiliation
Government Ayurveda college Trivandrum
Address
Department of shalyatantra, 3rd floor room - sushruta hall, op room 3, Government ayurveda medical college and hospital, NH 66 Vanchiyoor, trivandrum, kerala
Thiruvananthapuram KERALA 695001 India
Phone
9947035121
Fax
Email
remyarenjith3487@gmail.com
Source of Monetary or Material Support
Government ayurveda college, Thiruvananthapuram
Primary Sponsor
Name
nil
Address
nil
Type of Sponsor
Other [nil]
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 Sourav KT
Goverment Ayurveda College, Thiruvananthapuram
Department of shalyatantra, 3rd floor, room - sushruta hall, op room 3 Government Ayurveda Medical College and Hospital, NH66, Vanchiyoor PIN 695001 Thiruvananthapuram KERALA
9995671529
dr.sourav.kt@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethical committee Government Ayurveda college,Trivandrum
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:M501||Cervical disc disorder with radiculopathy. Ayurveda Condition: VISVACI,
(Procedure Reference: charak samhita, Procedure details: after 7 days of churna pottali sveda & 7 days of abhyanga virechana as a mild purgation is done on the 15th day) (1) Medicine Name: gandharvahastadi eranda tailam, Reference: ashtanga hrudayam, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 1 Days
Inclusion Criteria
Age From
20.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
Participants with clinically diagnosed Cervical radiculopathy
ExclusionCriteria
Details
Acute trauma to cervcal spine, fracture of cervical spine, cervical rib, congenital abnormalities in the cervical region, known case of monoplegia, hemiplegia, paraplegia, quadriplegia, participants with uncontrolled diabetes mellitus and hypertension, pregnant and lactating women.
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
Case Record Numbers
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
pain
0th day before and after treatment, 7th day,15th day
Secondary Outcome
Outcome
TimePoints
Motor strength
0th day before and after treatment, 7th day,15th day
Sensation of Dermatomes
0th day before and after treatment, 7th day,15th day
Triceps tendon reflex
0th day before and after treatment, 7th day,15th day
Spurling test
0th day before and after treatment, 7th day,15th day
Bakody sign
0th day before and after treatment, 7th day,15th day
Target Sample Size
Total Sample Size="30" Sample Size from India="30" Final Enrollment numbers achieved (Total)= "30" Final Enrollment numbers achieved (India)="30"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Cervical
radiculopathy is a neurological condition affecting the cervical nerve roots
due to intervertebral disc herniations or degenerative changes of the neural
foramen. It is characterised by pain in the neck radiating to the upper limb,
motor dysfunction and numbness. Diminished triceps tendon reflex occurs in more
than half of the cases. Cervical radiculopathy is having a prevalence of 3.5
cases per 1000 population.
Viswachi is a vatavyadhi
characterised by features like
‘bahu chesta apaharini’or ‘bahu karmakshayakari’due to affliction of ‘kandara’ of upper limb by vata.
Considering the etiopathogenesis and clinical features,viswachi
can
be corelated to cervical radiculopathy.
Ayurveda classic have explained 107
vital points in the human body termed as marma. They are defined as the confluence of mamsa, sira,
snayu, asthi and sandhi7 and as the sites where prana
resides. The traditional practice of marma explor