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CTRI Number  CTRI/2023/09/057661 [Registered on: 15/09/2023] Trial Registered Prospectively
Last Modified On: 07/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   An Ayurvedic Managenment of Uttana Vatarakata Vis-A-Vis Varicose Veins with Seka, Nitya Virechana and Kokilakshadi Kashaya 
Scientific Title of Study   Evaluation of combined effect of Seka, Nitya Virechana and Kokilakshadi Kashaya in the management of Uttana Vatarakta vis-à-vis Varicose Veins – An Open Label Single Arm Clinical Study.  
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 Dhanashree S 
Designation  PG Scholar 
Affiliation  JSS Ayurevda Medical College and Hospital 
Address  Department of PG Studies in Panchakarma JSS Ayurevda Medical College and Hospital Lalithadripura road Alanahalli Mysuru- 570028

Mysore
KARNATAKA
570028
India 
Phone  9535342997  
Fax    
Email  sdhanashree11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyoti 
Designation  Reader 
Affiliation  JSS Ayurevda Medical College and Hospital 
Address  Department of PG Studies in Panchakarma JSS Ayurevda Medical College and Hospital Lalithadripura road Alanahalli Mysuru- 570028

Mysore
KARNATAKA
570028
India 
Phone  9743517652  
Fax    
Email  jyotivhullale@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyoti 
Designation  Reader 
Affiliation  JSS Ayurevda Medical College and Hospital 
Address  Department of PG Studies in Panchakarma JSS Ayurevda Medical College and Hospital Lalithadripura road Alanahalli Mysuru- 570028


KARNATAKA
570028
India 
Phone  9743517652  
Fax    
Email  jyotivhullale@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurevda Medical College and Hospital Lalithadripura road Alanahalli Mysuru 
 
Primary Sponsor  
Name  Dr Dhanashree S 
Address  JSS Ayurevda Medical College and Hospital Lalithadripura road Alanahalli Mysuru 
Type of Sponsor  Other [self] 
 
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 Dhanashree S  JSS Ayurveda Medical College and Hospital   Room NO.6,Department of PG Studies in Panchakarma JSS Ayurevda Medical College and Hospital Lalithadripura road Alanahalli Mysuru- 570028Department of PG Studies in Panchakarma JSS Ayurevda Medical College and Hospital Lalithadripura road Alanahalli Mysuru- 570028
Mysore
KARNATAKA 
9535342997

sdhanashree11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Ayurveda Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I831||Varicose veins of lower extremities with inflammation. Ayurveda Condition: UTTANA-VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Samhitha, Procedure details: Nitya virechana for 7 days(1st - 7th day) with Nimbamritadi Eranda Taila - 20-40ml according to the koshta, in empty stomach, around 8-9am. All the procedures will be done according to the standardised operative procedure protocol. )
2Intervention ArmProcedure-sekaH, सेकः (Procedure Reference: Samhitha, Procedure details: Ekanga Dashamula Ksheera Kashaya Seka : for 7 days(1st-7th day) Purva Karma : Application of Sahacharadi Taila to lower limbs. Pradhana Karma : Ekanga Dashamula Ksheera Kashaya Seka to lower limbs in empty stomach, for 20min around 7-8am)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects who fulfill diagnostic criteria.
Subjects of age group 20- 65 years, irrespective of gender.
Subjects who are fit for Nitya Virechana and Kashaya Seka.


 
 
ExclusionCriteria 
Details  Subjects having Varicose Veins associated with Venous Ulcer, Deep Vein Thrombosis or Cellulitis.
Subjects with other systemic diseases that would interfere with the study like uncontrolled Diabetes Mellitus, uncontrolled Hypertension, etc.,
Pregnant women and lactating mothers.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Combined effect of Seka Nitya Virechana with internal administration of Kokilakshadi Kashaya in reduction of signs and symptoms of Uttana Vatarakta vis-a-vis Varicose Veins  0thday- before treatment
8thday- after seka nityavirechana
28thday- after treatment
 
 
Secondary Outcome  
Outcome  TimePoints 
Combined effect of Seka Nitya Virechana with internal administration of Kokilakshadi Kashaya in reduction of signs & symptoms of Uttana Vatarakta vis-a-vis Varicose Veins  28 days
 
 
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 2 
Date of First Enrollment (India)   21/09/2023 
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="5"
Days="30" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
  Vatarakta is the condition caused by Dushti of Vata and Rakta ,where Prakupita Rakta does Dushana and Margavarana of Vata and Dushita Vata further does Dushana of Rakta. Vatarakta is of 2 types-Uttana and Gambhira. Uttana Vatarakta Lakshanas are Kandu, Daha, Ruk, Ayama etc. 

   Uttana Vatarakta can be co-related to Varicose Veins due to similarity in its symptoms.

 Varicose veins are dilated tortuous, superficial veins that results from defective structure and functions of valves of saphenous veins, intrinsic weakness of the vein wall, high intraluminal pressure. Its incidence is 5% among Indian population with more prevalence in women, obese and occupation that requires prolong standing. Symptoms of varicose veins are dilated veins, dragging pain, night cramps, pigmentation of skin, pedal edema, heaviness, burning and itching sensation of lower limbs .

 Intervention as per contemporary science is Surgical and Non-surgical methods. Surgical interventions includes stripping and ablation therapy. This may lead to complications like infection, hematoma, etc. Non-surgical interventions include elevation of limbs, compression stockings and sclerotherapy. This may lead to complications like  hyperpigmentation, allergic reactions to sclerosants, etc with higher recurrence rate. Hence, it is the need of hour to find effective treatment for the better relief and arrest the further progression of the disease.

In Ayurveda, Nidana parivarjana, Shodhana, Shamana are the common line of protocol in the management of disease. Snehayukta Virechana is explained as the treatment in Vatarakta and Seka in Uttana Vatarakta.  As, many works have been carried out on classical Virechana, Nitya Virechana and Seka is selected in the present study.

Hence, an effort is made to know the combined effect of Nitya Virechana with Nimbamritadi Eranda Taila, Dashamula Ksheera Kashaya Seka with internal administration of Kokilakshadi Kashaya in the management of Uttana Vatarakta. 

 

 

 

 
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