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CTRI Number  CTRI/2024/08/072954 [Registered on: 23/08/2024] Trial Registered Prospectively
Last Modified On: 22/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing the effectiveness of medicinal leeches for varicose veins. One group of leeches previously vomited blood after turmeric powder treatment, while the other group used the mixture of rock salt and sesame oil. The aim was to see which treatment improved therapy outcomes. 
Scientific Title of Study   Effect of Murchita Tilataila Yukta Saindhava Lavana and Haridra Choorna in Pashchat Karma of Jalaukavacharana with special reference to Jalauka Vamana. 
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 S Murali Krishna  
Designation  PG scholar 
Affiliation  Sri Dharmastala Manjunatheshwara College and Hospital of Ayurveda,Hassan 
Address  Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital BM Road Tanniruhalla Hassan Karnataka India-573201

Dakshina Kannada
KARNATAKA
573201
India 
Phone  6363145825  
Fax    
Email  muralinaravi6@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gopikrishna B J  
Designation  Professor and HOD, department of Shalya tantra 
Affiliation  Sri Dharmastala Manjunatheshwara College and Hospital of Ayurveda,Hassan 
Address  Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital BM Road Tanniruhalla Hassan Karnataka India-573201

Hassan
KARNATAKA
573201
India 
Phone  9886360901  
Fax    
Email  drgopiboyapati@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S Murali Krishna  
Designation  Pg scholar-Department of Shalyatantra , OPD number 12  
Affiliation  Sri Dharmastala Manjunatheshwara College and Hospital of Ayurveda,Hassan 
Address  Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital BM Road Tanniruhalla Hassan Karnataka India-573201
S/O Dr S Suryananarana , Pranava house panal road, Naravi post and village Beltangady Taluk Karnataka India-573201
Dakshina Kannada
KARNATAKA
573201
India 
Phone  6363145825  
Fax    
Email  muralinaravi6@gmail.com  
 
Source of Monetary or Material Support  
Department of shalya tantra,OPD No.11 and 12,Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital BM Road Thanniruhalla Hassan Karnataka India 573201  
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan  
Address  Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India 
Type of Sponsor  Private medical college 
 
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 Murali Krishna  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Hassan 573201   Department of Shalya tantra OPD No. 12,11 Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital, Thanniruhalla, B M Road, Hassan-573201 Karnataka India
Hassan
KARNATAKA 
6363145825

muralinaravi6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I868||Varicose veins of other specifiedsites. Ayurveda Condition: SIRAJAGRANTHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-jalaukAvacaraNam, जलौकावचरणम् (Procedure Reference: Sushruta samhita , 13 th chapter Jalaukavacharaneeya adhyaya , Procedure details: Day 1-Jalaukavacharana. Day 2-observation of the Jalauka Following the jalaukavacharana the proper vomitting of Jalauaka is ensured by applying Haridra churna to the face of the Jalauka and compairing with mixture of saindhava and thila taila and observing the jalauka for the next day.The subject is observed after jalaukavacharana for 12 hours. )
(1) Medicine Name: saindhava lavana, tila taila , Reference: sushruta samhita, sutra sthana 13 chapter, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 2(g), Frequency: sos, Duration: 1 Days
2Comparator ArmProcedure-jalauaka vamana (Procedure Reference: Sushruta samhita,sutra sthana , 13 th chapter Jalaukavacharaneeya adhyaya, Procedure details: Day 1-Jalaukavacharana. Day 2-observation of the Jalauka Following the jalaukavacharana the proper vomitting of Jalauaka is ensured by applying Haridra churna to the face of the Jalauka and compairing with mixture of saindhava and thila taila and observing the jalauka for the next day.The subject is observed after jalaukavacharana for 12 hours. ) )
(1) Medicine Name: Haridra , Reference: Sushruta samhita,sutra sthana , 13 th chapter Jalaukavacharaneeya adhyaya, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: sos, Duration: 1 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Subjects aged between 18-70 years will be selected
2.Subjects having dilated and tortuous veins
 
 
ExclusionCriteria 
Details  1.Subjects who are affected with any of the communicable disease.
2.Multiple times application of Jalauka.
3.Patient under any modern blood thinner medications.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The quantity of blood which is vomitted by the Jalauka during Jalauka vamana.  Baseline, Secend day and After One week 
 
Secondary Outcome  
Outcome  TimePoints 
Duration required to stop bleeding, the intensity of pain reduced.   Will be assesed Baseline 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   12/09/2024 
Date of Study Completion (India) 28/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [muralinaravi6@gmail.com].

  6. For how long will this data be available start date provided 01-06-2024 and end date provided 01-06-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

  Jalukavacharana, a prominent therapeutic practice in Ayurveda, has demonstrated its effectiveness in addressing a wide spectrum of diseases. This traditional method involves the application of medicinal leeches (Jalauka) to patient’s skin, with the leeches subsequently reused after a week. However, recent observations in Ayurveda institutions have raised concerns about untoward incidents such as cellulitis at the Jalauka bite site and increased mortality of the leeches. One critical aspect of maintaining the vitality of Jalauka after Jalukavacharana is the process of Vamana, wherein unhealthy blood is offered to the leech. Ensuring the proper execution of Vamana becomes pivotal in preventing a reduction in the quality of subsequent Jalukavacharana treatments. While contemporary practitioners often employ Haridra Choorna for Vamana, classical Ayurvedic texts such as Sushruta Samhita, Asthanga Hridaya, and Astanga Sangraha prescribe a mixture of Murchita Tila Taila and Saindhava Lavana for this purpose. Astanga Hridaya, in its commentary, elucidates a test to ascertain the adequacy of Vamana. It describes that the Jalauka sinks in fresh water and remain inactive if Vamana has been conducted improperly. Additionally, the commentary explains a diagnostic test to identify Indramada, a disease condition in leeches resulting from inadequate Vamana.

Procedure:Pre-operative phase: Good leeches are collected from marshy areas and activated by soaking them in turmeric water. The patient undergoes proper oleation and sudation.Main procedure: Leeches attach themselves to the targeted area, sucking impure blood. Their saliva contains unique enzymes, including hirudin, which acts as a potent anticoagulant.Post-operative care: Leeches are made to vomit the blood they’ve consumed. The bitten area is cleaned and bandaged with turmeric and honey.Leech care: Proper vomiting of blood ensures the leech’s recovery and strength. Leeches are stored separately after treatment.

Specialty of Leeches: Leeches can suck blood through anterior orifices. They are classified into two types: Savisha (poisonous) and Nirvisha (non-poisonous).Leeches thrive in cold, damp environments and are particularly useful for pittaja (related to excess Pitta dosha) conditions.

Benefits for Varicose Veins:Leech therapy improves blood circulation and prevents clot formation. Hirudin, found in leech saliva, acts as a powerful anticoagulant, making it beneficial for managing varicose veins.

 
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