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CTRI Number  CTRI/2024/11/076147 [Registered on: 01/11/2024] Trial Registered Prospectively
Last Modified On: 20/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical research to find the effect of Leech Therapy in Varicose Ulcer Treatment. 
Scientific Title of Study   An open realistic prospective interventional clinical trial to evaluate the efficacy of medicinal leech therapy (Jalaukavacarana) in the treatment of Varicose Ulcer.  
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 J Hareendran Nair  
Designation  MANAGING DIRECTOR 
Affiliation  PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE AND PG CENTRE. 
Address  ROOM NO. 1 , KAYACHIKITSA , PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE AND PG CENTRE. KILLY, KATTAKADA

Thiruvananthapuram
KERALA
695572
India 
Phone  9447096201  
Fax    
Email  hareendrannair@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Kaveri Nair A  
Designation  ASSISTANT PROFESSOR 
Affiliation  PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE AND PG CENTRE. 
Address  ROOM NO. 2 , DEPARTMENT OF SALYATANTRA , PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE AND PG CENTRE. KILLY , KATTAKADA

Thiruvananthapuram
KERALA
695572
India 
Phone  7994461126  
Fax    
Email  dr.kaverinair@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kaveri Nair A  
Designation  ASSISTANT PROFESSOR 
Affiliation  PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE AND PG CENTRE. 
Address  ROOM NO. 2 , DEPARTMENT OF SALYATANTRA , PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE AND PG CENTRE. KILLY , KATTAKADA


KERALA
695572
India 
Phone  7994461126  
Fax    
Email  dr.kaverinair@gmail.com  
 
Source of Monetary or Material Support  
Department Of Science and Technology, SHRI , Government Of India,Technology bhavan, New Delhi - 16 
 
Primary Sponsor  
Name  Department Of Science and Technology SHRI  
Address  Technology bhavan, New Delhi - 16 
Type of Sponsor  Government funding agency 
 
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 Kaveri Nair A  Pankajakasthuri Ayurveda Medical College & PG Centre  Room No: 2, Department of Shalyatantra, Pankajakasthuri Ayurveda Medical College & PG Centre,
Thiruvananthapuram
KERALA 		 7994461126

dr.kaverinair@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I830||Varicose veins of lower extremities with ulcer. Ayurveda Condition: SIRAGATAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Medicinal Leech Therapy (Procedure Reference: Susruta Samhita, sutrasthana, !3th Chapter (Jalaukavacarana), Procedure details: Medicinal Leech Therapy for bloodletting technique.)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects of age group 20 - 70 years, irrespective of gender, religion, caste, occupation and socioeconomic status.
2. Signs and symptoms of varicose ulcers.
 
 
ExclusionCriteria 
Details  1. Subjects diagnosed with bleeding disorders
2. Diagnosed with ulcers due to sexually transmitted infections.
3. Diagnosed with tuberculosis, malignancy, leprosy and osteomyelitis.
4. Diagnosed with HIV.
5. Diagnosed with Anaemia.
6. Uncontrolled Diabetes Mellitus
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain (VAS SCALE), wound healing , leg Ulcer tools  0th day, 15th day, 30th day, 45th day and 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
quality of life(using validated quality of life questionnaire)  0th , 15th day, 30th day, 45th day and 60th day. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   09/11/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Bloodletting by means of Jalouka (leech) is called Jaloukavacharana in Ayurveda literature. Jalouka is considered the best among the Sastras (surgical instruments) and Anusastras (para surgical instruments). Jaloukavacharana is applied by Ayurvedic practitioners in the management of various dermatological conditions, chronic non-healing ulcers, deep vein thrombosis. Varicose ulcers (venous insufficiency ulcers) are wounds that occur due to improper functioning of venous valves 70% to 90% of leg ulcers are venous in origin. Venous ulcers develop mostly along the medial distal part of leg and can be painful; the ulcer may get infected leading to cellulitis or gangrene. Ayurveda also mention about chronic ulcers. In Susrutha Samhita, Sutrasthana Chapter13 information regarding the  Jalukavacharana are there.

The current study will be a prospective interventional clinical trial to evaluate the efficacy of medicinal leech therapy (Jalaukavacharana) in the treatment of varicose ulcer.Leech therapy mentioned in ayurvedic classics for Ulcer management is adopted here for better understanding and standardization of the procedure. Jalaukavacarana will be done daily after following the procedure as per the classical references in Ayurveda. In this study we are planning to do intervention in 100 subjects who satisfies the inclusion criteria.

            The initial assessment will be done before the commencement of the study. The assessment parameters include Demographic data, Medical history (includes systemic examination),Vital signs (Blood pressure, Heart rate , Pulse rate,temperature),Past surgical history, Laboratory investigations include Fasting blood sugar,Post prandial blood sugar,HbA1c,Hb,TC,DC,ESR,Bleeding time, Clotting time, HIV,HbsAg, Doppler venous study, Wound assessment tool( LEG ULCER) for qualitative analysis and Pain assessment ( VAS score). Further assessment will be done on the day 15 (visit 2), day 30 (visit 3), day 45 (visit 4) and day 60 (visit 5). Qualitative and Quantitative analysis of data regarding wound healing will be statistically Analysed.

 
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