| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I868||Varicose veins of other specifiedsites. Ayurveda Condition: SIRAJAGRANTHIH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ| (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 | | 2 | Comparator Arm | Procedure | - | 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 |
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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.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant Blinded |
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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 |
|
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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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [muralinaravi6@gmail.com].
- 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.
- 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. |