CTRI

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CTRI Number

CTRI/2021/02/031542 [Registered on: 25/02/2021] Trial Registered Prospectively

Last Modified On:

30/05/2022

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Siddha

Study Design

Single Arm Study

Public Title of Study

A Clinical study on cervical spondylosis using thengaai thuruval ottradam (external therapy)

Scientific Title of Study

A clinical study to evaluate the therapeutic efficacy of THENGAAI THURUVAL OTTRADAM [External Therapy] in the management of CEGANA VATHAM [CERVICAL SPONDYLOSIS]

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr M F Muhammad Hafeez
Designation	PG scholar
Affiliation	Government Siddha medical college and hospital
Address	PG Pura Maruthuvam OP No 4 Government Siddha medical college and hospital Palayamkottai Tirunelveli PG Pura Maruthuvam OP No 4 Government Siddha medical college and hospital Palayamkottai Tirunelveli TamilNadu Tirunelveli TAMIL NADU 627002 India
Phone	9443882877
Fax
Email	hafeezmf75@gmail.com

Details of Contact Person
Scientific Query

Name	Dr M Ahamed Mohideen MDs
Designation	Associate Professor
Affiliation	Government Siddha medical college and hospital
Address	PG Pura Maruthuvam OP No 4 Government Siddha medical college and hospital Palayamkottai Tirunelveli PG Pura Maruthuvam OP No 4 Government Siddha medical college and hospital Palayamkottai Tirunelveli Tirunelveli TAMIL NADU 627002 India
Phone	9442542282
Fax
Email	dr.ahmed63@gmail.com

Details of Contact Person
Public Query

Name	Dr M Ahamed Mohideen MDs
Designation	Associate Professor
Affiliation	Government Siddha medical college and hospital
Address	PG Pura Maruthuvam OP No 4 Government Siddha medical college and hospital Palayamkottai Tirunelveli PG Pura Maruthuvam OP No 4 Government Siddha medical college and hospital Palayamkottai Tirunelveli TAMIL NADU 627002 India
Phone	9442542282
Fax
Email	dr.ahmed63@gmail.com

Source of Monetary or Material Support

OPD and IPD facilities and Central Library of Government Siddha medical college and hospital

Primary Sponsor

Name	Government Siddha medical college and hospital
Address	PG Pura Maruthuvam OP No 4 Government Siddha medical college and hospital Palayamkottai Tirunelveli TamilNadu
Type of Sponsor	Government medical college

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 M F Muhammad Hafeez	Government Siddha medical college and hospital	Government Siddha medical college and hospital Palayamkottai Tirunelveli TAMIL NADU	9443882877 hafeezmf75@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
IEC	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M478\|\|Other spondylosis,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Not applicable	Not applicable
Intervention	THENGAAI THURUVAL OTTRADAM (EXTERNAL THERAPY)	ottradam will be given once a day for 48 days

Inclusion Criteria

Age From	25.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	Neck pain Radiating pain to upper limbs With or without numbness in the upper limbs Giddiness and neck stiffness Patients who are willing to give blood samples for laboratory investigation Patients who are willing to take X-ray before and after treatment Willing for admission in IPD for 48 days or willing to attend OPD regularly Patients who are willing to participate in this study with knowledge of potential risks and who are willing to sign the informed consent

ExclusionCriteria

Details

Cardiac disease
Tuberculosis in spine
Spina bifida
Use of narcotic drugs
Pregnant women and lactating mother
Trauma, Fracture, Ligament injury
Patient with any other serious illness.
Benign and malignant neoplasm
Congenital spinal anomalies
Dermatological issues

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Improvement in lab parameters and relief of clinical symptoms	48 days

Secondary Outcome

Outcome	TimePoints
Reduction inrestriction of movements To evaluate effect of ottradam To study the siddha principles before and after treatment	48 days

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40"

Phase of Trial

Phase 2

Date of First Enrollment (India)

01/03/2021

Date of Study Completion (India)

28/04/2022

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details
Modification(s)

Nil

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary
Modification(s)

The study is A Clinical study to evaluate the therapeutic efficacy of THENGAAI THURUVAL OTTRADAM in the management of cegana vatham (cervical spondylosis). The trial will be given externally as a ottradam therapy for 48 days in 40 patients. The trial period of 12 months will be carrying out in government Siddha medical college and hospital, Palayamkottai Tirunelveli TamilNadu. Primary outcome is improvement in lab parameters and relief of clinical symptoms. The secondary outcome is reduction in restriction of movements and evaluate the effect of ottradam. In case of any adverse event (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patient will be given in OPD facility.