CTRI

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CTRI Number

CTRI/2025/02/081206 [Registered on: 24/02/2025] Trial Registered Prospectively

Last Modified On:

21/02/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Siddha

Study Design

Single Arm Study

Public Title of Study

Thokkanam and otradam for kumbavatham (Adhesive capsulitis)

Scientific Title of Study

An open single arm clinical trial to evaluate the therapeutic effect of thokkanam with thazhuthalai thailam and valinoi otradam for the management of kumbavatham( Adhesive capsulitis)

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 E Kirubanithi
Designation	PG scholar
Affiliation	National institute of siddha
Address	Department of pura Maruthuvam National institute of Siddha Tambaram sanatorium Chennai Chennai TAMIL NADU 600047 India
Phone	8248673273
Fax
Email	kirubakirubanithi829@gmail.com

Details of Contact Person
Scientific Query

Name	Dr M V Mahadevan
Designation	Associate professor
Affiliation	National institute of siddha
Address	Department of pura Maruthuvam National institute of Siddha Tambaram sanatorium Chennai Chennai TAMIL NADU 600047 India
Phone	9840417565
Fax
Email	puramaruthuvam@gmail.com

Details of Contact Person
Public Query

Name	Dr M V Mahadevan
Designation	Associate professor
Affiliation	National institute of siddha
Address	Department of pura Maruthuvam National institute of Siddha Tambaram sanatorium Chennai Chennai TAMIL NADU 600047 India
Phone	9840417565
Fax
Email	puramaruthuvam@gmail.com

Source of Monetary or Material Support

National institute of siddha Tambaram sanatorium Chennai-47

Primary Sponsor

Name	National institute of siddha
Address	National institute of siddha Tambaram sanatorium Chennai-47
Type of Sponsor	Research institution and hospital

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 E Kirubanithi	National institute of siddha	Department of pura Maruthuvam National institute of Siddha Tambaram sanatorium Chennai Chennai TAMIL NADU	8248673273 kirubakirubanithi829@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee,National institute of siddha	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M750\|\|Adhesive capsulitis of shoulder,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	nil	nil
Intervention	Thazhuthalai thailam thokkanam and valinoi otradam	thokkanam will be done with thazhuthalai thailam for 30 minutes and ottradam will be given for 15 minutes using vali noi otradam for 21 days

Inclusion Criteria

Age From	30.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	age: 30-65 years all genders Pain, tenderness, and Stiffness present in the shoulder joint Loss of active and passive range of movements (Abduction, external rotation, internal rotation). SPADI Score greater than 20 and less than 80.

ExclusionCriteria

Details

K/C/O infective arthritis.
K/C/O dislocation and subluxation of the shoulder joint.
Fracture around the shoulder region.
Any other serious systemic illness.
Cervical spondylosis.
• Uncontrolled diabetes.
• Pregnant and lactating women.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
The expected outcome of the study will reveal the therapeutic effect of Thokkanam with Thazhuthalai thailam and valinoi otradam in reducing the clinical signs and symptoms of kumbavatham assessed by using the SPADI Scale and Goniometric measurements.	Baseline, each week until 5th week

Secondary Outcome

Outcome	TimePoints
improvement in quality of life	Baseline, each week until treatment of 5th week

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
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 3

Date of First Enrollment (India)

11/03/2025

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="6"
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

INTRODUCTION

The Siddha system of medicine is one of the traditional systems of medicine prevalent in South India. Thokkanam is one of the oldest and simplest forms of Siddha treatment. It improves muscle tone, stimulates blood circulation, and helps eliminate waste products throughout the body. At its best, Thokkanam can potentially restore the individual’s physical and mental 4 health. Otradam is an effective and potential therapy to alleviate musculoskeletal disorders. Adhesive Capsulitis describes a pathological process in which the body forms excessive scar tissue or adhesions across the glenohumeral joint, leading to stiffness, pain, and dysfunction. In Yugi Vaidhya Chinthamani, vatha diseases are classified into 80 types. Kumbavatham is characterized by pain, restricted movements in the shoulder joint and arm, burning sensation in eyes and cheeks, giddiness and twitching over the scalp, pain below the umbilicus, and burning sensation in the tongue.

OBJECTIVE: To evaluate the therapeutic effect of Thokkanam with Thazhuthalai thailam and Valinoi otradam in reducing the clinical signs and symptoms of Kumbavatham (Adhesive capsulitis) assessed by using the SPADI scale and Goniometric measurements.

METHODOLOGY:

STUDY DESIGN : An open single-arm clinical trial. STUDY TYPE : Interventional study STUDY PLACE : Pura maruthuvam OPD, Ayothidoss Pandithar Hospital, National Institute of Siddha, Chennai-47. SAMPLE SIZE : 30 SAMPLING METHOD : Consecutive sampling STUDY PERIOD : 18 months STUDY INTERVENTION : Thokkanam and Otradam.

FREQUENCY OF TREATMENT PROCEDURE: (Total-35 days)

• Session 1: Consecutively for 7 days • Rest for another 7 days • Session 2: Consecutively for another 7 days • Rest for another 7 days • Session 3: Consecutively for another 7 days

TESTS AND ASSESSMENTS:

1. Clinical assessment. 2. Siddha system of examination. 3. Routine laboratory investigations. 4. Special test

EXPECTED OUTCOME OF THE STUDY:

The expected outcome of the study will reveal the therapeutic effect of Thokkanam with Thazhuthalai thailam (External) and Valinoi Otradam in reducing the clinical signs and symptoms of Kumbavatham (Adhesive capsulitis) assessed by using the SPADI scale (Shoulder pain and disability index) and goniometric measurements from the baseline assessment with Minimally clinically Important Difference (MCID) of 8 and 13 points.