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CTRI Number  CTRI/2024/07/070920 [Registered on: 19/07/2024] Trial Registered Prospectively
Last Modified On: 19/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha
Other (Specify) [VARMAM MANIPULATION]  
Study Design  Single Arm Study 
Public Title of Study   A Study on Arkathy Thailam for the management of Kumbavatham (Periarthritis Shoulder) 
Scientific Title of Study   An Open Clinical Trial On Varmam Manipulation (Varma Thadaval) With Arkathy Thailam For The Management Of Kumbavatham (Periarthritis Shoulder) Reporting At Ayothidoss Pandithar Hospital,National Institute Of Siddha. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  S Baggiyavelan 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Department Of Varma Op No 15 National Institute Of Siddha Tambaram Sanatorium Chennai

Chennai
TAMIL NADU
600047
India 
Phone  8248132540  
Fax    
Email  baggiyavelan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.N J Muthukumar 
Designation  Associate Professor And Head Of The Department 
Affiliation  National Institute Of Siddha  
Address  Department Of Varma Op No 15 National Institute Of Siddha Tambaram Sanatorium Chennai

Chennai
TAMIL NADU
600047
India 
Phone  9962006843  
Fax    
Email  njmuthukumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr D Periyasami 
Designation  Associate Professor And Head Of The Department 
Affiliation  National Institute Of Siddha  
Address  Department Of Varma Op No 15 National Institute Of Siddha Tambaram Sanatorium Chennai

Chennai
TAMIL NADU
600047
India 
Phone  7358481734  
Fax    
Email  sami2011nis@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Siddha Tambaram Sanatorium Chennai 600047 
 
Primary Sponsor  
Name  National Institute Of Siddha 
Address  Department Of Varma Op No 15 National Institute Of Siddha Tambaram Sanatorium Chennai  
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 S Baggiyavelan  Ayothidoss Pandithar Hospital  Departmnent of varma maruthuvam op no 15 National Institute of Siddha Tambaram Sanatorium
Chennai
TAMIL NADU 		 8248132540

baggiyavelan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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 
Intervention  Arkathy thailam  Varmam manipulation with 70 ml of Arkathy thailam weekly once for 48 days as external application. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.SPADI score greater than 20 but less than 70
2.patient who are willing to give radiological investigation and blood sample for lab investigation
3.Patients who are willing to sign the informed consent 
 
ExclusionCriteria 
Details  1.K/H/O uncontrolled diabetes mellitus
2. K/H/O of recent upper extremity injury and/or fractures,
3.K/H/O Infective arthritis
4.K/H/O Dislocation of shoulder joint
5. Pregnancy and lactating women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
SPADI score less than 20%
Reduction in pain
Improvement in Range of Movement 		 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/07/2024 
Date of Study Completion (India) 01/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
BACKGROUND: Siddha system is one of the ancient system of medicine for maintaining healthy life and for the treatment for diseases. This system was bestowed by the great Siddhars after attaining spiritual knowledge through physical perfection and spiritual salvation. Varmam is one of the unique therapeutic procedure of Siddha system of Medicine. Varmam points in the body can be determined by anatomical location, finger breadth measurement, thread measurement.
Varmam is one of the component of martial arts. It may possess therapeutic approaches and medicines to cure ailments. There are numerous vital points in the human body that are located in the junction of nerves, bones, muscles, ligaments, internal organs. These are interconnected by channels in definite way and governing on various vital activities of human body. when we regulate these vitals points using different manipulation technique it produces therapeutic efficacy. There are 108 Varmam points in human body. Apart from these points, many Varmam points are mentioned in Varmam literatures.In Yugi Vaidhya Chinthamani, vatha diseases are classified into 80types.Kumbavatham is one among 80 types of Vatha diseases. Kumbavatham is characterized by pain,restricted movements in shoulder joint an darm,burning sensation in eyes and cheeks,giddiness and twitching over the scalp, pain below the umbilicus,burning sensation in the tongue.In modern medicine kumba vatham may be correlated with Periarthritis shoulder.Adhesive capsulitis, also known as “frozen shoulder,” is a common shoulder disease that clinically presents with pain, stiffness, and dysfunction and is pathologically characterized by inflammation and contracture of the glenohumeral capsule. Although there are differences in the literature, adhesive capsulitis has a high prevalence rate of 2–5% in the general population, with the highest prevalence observed among women between 40 and 60 years of age. Adhesive capsulitis consists of the first “freezing (painful)” stage with increased pain and stiffness for several months, a second “frozen (stiff)” stage resulting in loss of rangeof motion (ROM) of the shoulder, and a third “thawing (recovery)” stage, in which pain and ROM recover.
A shoulder pain and disability index (SPADI) was used to measure the pain and disability associatedwithshoulderpathology.TheSPADI is a self-administered index consisting of 13 items divided into two subscales: pain and disability.
The universal goniometer(orinternational standard goniometer)is the most commonly used tool for measuring ROM at large joints, such as the shoulder and hip. A joint’s ROM is usually measured by the number of degrees from the starting position of a segment to its position at the end of its full range of the movement.The most common way this is done is by using a double-armed goniometer
. Although there is conventional management like NSAID, intraarticular steroids, physiotherapy, acupressure and yoga, the recovery from this condition is prolonged. The Siddha system of medicine is one of the ancient systems that practised in India possess various treatment modalities to treat various musculoskeletal conditions. Varmam therapy is a non-invasive therapy used in pain management
OBJECTIVE: 
To evaluate the effectiveness of Varmam manipulation (Varma thadaval) with Arkathy thailam(external) in the management of Kumbavatham (PERIARTHRITIS SHOULDER) using SPADI scale and Goniometer.

METHODOLOGY: A total of 30 diagnosed patients of Kumbavatham (Periarthritis Shoulder)
within the age limit of 30 to 60 years willing to participate in the study by signing the consent form
will be enrolled in the study based on inclusion criteria. patient with  uncontrolled diabetes mellitus ,recent upper extremity injury and/or fractures,  , Infective arthritis , Dislocation of shoulder joint , Pregnancy and lactating women will be excluded

OUTCOME: 
  1. SPADI score less than 20%
  2. Reduction in pain
  3. Improvement in Range of Movement
RESULTS AND DISCUSSION : The result will be statistically analysed
KEYWORDS: Arkathy thailam,Varmam manipulation,Periarthritis shoulder.
 
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