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CTRI Number  CTRI/2024/06/068899 [Registered on: 13/06/2024] Trial Registered Prospectively
Last Modified On: 04/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha
Other (Specify) [Siddhar Yogam therapy]  
Study Design  Single Arm Study 
Public Title of Study   Yoga for the management of Varicose veins 
Scientific Title of Study   A Pilot study on Siddhar Yogam in the management of Varicose veins (Narambu Kirandhi) in patients 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  Dr V R Manobala 
Designation  Postgraduate Scholar 
Affiliation  National Institute of Siddha 
Address  Room no 13, Department of Siddhar Yoga Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai 600047

Kancheepuram
TAMIL NADU
600047
India 
Phone  9994967103  
Fax    
Email  vimanobala@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr V Mahalakshmi 
Designation  Associate Professor & Head of the Department(i/c) 
Affiliation  National Institute of Siddha 
Address  Room no 13, Department of Siddhar Yoga Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai 600047

Kancheepuram
TAMIL NADU
600047
India 
Phone  9444519975  
Fax    
Email  rvmahalakshmi85@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr V MAHALAKSHMI 
Designation  Associate Professor & Head of the Department(i/c) 
Affiliation  National Institute of Siddha 
Address  Room no 13, Department of Siddhar Yoga Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai 600047

Kancheepuram
TAMIL NADU
600047
India 
Phone  9444519975  
Fax    
Email  rvmahalakshmi85@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, Kancheepuram, Tamil Nadu, 600047 
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 V R Manobala  Ayothidoss Pandithar Hospital  OPD Room no 13, Department of Siddhar Yoga Maruthuvam, Tambaram Sanatorium, Chennai-47
Kancheepuram
TAMIL NADU 		 9994967103

vimanobala@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: I839||Asymptomatic varicose veins of lower extremities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Siddhar Yogam Therapy  Relaxation techniques Uttanapadasanam Ardhahalsanam Vibarithakarani Padasanchalasanam Salabasanam Paschimottanasanam Shavasanam Thirumoolar Pranayamam, for 35 minutes twice a day in empty stomach for 90 days 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Patient with classical symptoms of Varicose veins CEAP grading C1, C2
2. Patient having the symptoms of Varicose veins up to 3 years
3. Patients who are willing for USG Doppler 
 
ExclusionCriteria 
Details  1. Pregnant and lactating mothers
2. Patients with Deep Vein Thrombosis
3. Recent surgical and traumatic history
4. Patients with known history of Chronic renal failure, Cardiac disorders, Diabetic ulcer, Varicose ulcer, Cellulitis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The outcome will be assessed by expected reduction in AVVQ
(Aberdeen Varicose Vein Questionnaire) 		 6 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)   25/06/2024 
Date of Study Completion (India) 25/11/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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   Varicose veins are convoluted, expanded, and stretched subcutaneous veins of the lower limbs and are the most frequently reported medical condition. This condition has a higher prevalence in Western and developed countries. Inadequacy of the valves results in reflux of blood in the veins of the lower leg. Varicose veins disease is turning out to be a global curative issue and a matter of great degree concern for the treatment of Varicose veins that can further transform into emotional disability, skin changes, inconvenience, and can influence personal satisfaction. So, reducing the intensity and improving the quality of life in patients with varicose veins plays an important role in the management. Therapeutic yoga is defined as the application of yoga postures and practice to the treatment of health conditions. Varicose veins management through Siddhar Yogam therapy would reduce the medication cost with positive health benefits This study aims to evaluate the effect of Siddhar Yogam in the management of Varicose veins.
Key words: Varicose veins, Yoga
 
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