| CTRI Number |
CTRI/2018/02/011872 [Registered on: 13/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CLINICAL STUDY ON EFFECTIVENESS OF JALAUKAVACHARANA(LEECH THERAPY) IN THE MANAGEMENT OF
VATARAKTA(BUERGER’S DISEASE) |
|
Scientific Title of Study
|
CLINICAL STUDY ON EFFECTIVENESS OF JALAUKAVACHARANA IN THE MANAGEMENT OF
VATARAKTA (BUERGER’s DISEASE) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr BHOOMI SONI |
| Designation |
P G SCHOLAR Dept Of Shalya Tantra |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
II-f-3 P.G block,
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9008637659 |
| Fax |
|
| Email |
bhoomi629@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRGOPIKRISHNA BJ |
| Designation |
M.S(AYU), (Ph.D) ASSOCIATE PROFESSOR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Dept Of Shalya Tantra
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9886360901 |
| Fax |
|
| Email |
drgopiboyapati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRGOPIKRISHNA BJ |
| Designation |
M.S(AYU), (Ph.D) ASSOCIATE PROFESSOR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Dept Of Shalya Tantra
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9886360901 |
| Fax |
|
| Email |
drgopiboyapati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan Karnataka India
|
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr BHOOMI SONI |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Department of Shalya Tantra,
Hassan
KARNATAKA |
9008637659
bhoomi629@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 BM Road Thanniruhalla Hassan Karnataka India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
VATARAKTA (BUERGER’S DISEASE), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
leech |
duration of application:-
once in 2 days for 3 sittings.(1st ,4th and 6th day)
Total duration of treatment 7days.
mode of administration:-
Purva Karma:-
For patient:- The patient is made either to sit or lie down, the area selected for application of Jalauka made rough by rubbing with either mud or fine powder of cow dung without causing pain.
For Jalauka:- The body of Jalauka should be smeared with solution of paste of Sarshapa and Haridra and kept in a water pot for a period of one Muhurta (28 minutes), the after knowing that they are free from fatigue it should be picked up and made to catch the place of the disease.
Pradhana Karma:-
Jalauka is to be applied on the site. Jalauka will bite on the skin and suck the blood itself. Its face appears like the hoof of a horse and it raises its neck by this we can understand that it has started sucking blood. As soon as Jalauka starts sucking, wet white gauze will be covered on it
Paschat Karma:-.
After sucking Shuddha Rakta patient gets itching and pain at the site, then it is removed by sprinkling Haridra churna at its mouth region and dressing will be done
|
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1.Smoking index (SI) > 300 [No. of cigarettes smoked per day x No. Of
years of smoking]
2.Pack years index (PYI) >40 [ No. of years of smoking x No of
packets of cigarettes per day]
3.Shiyanoya’s criteria for T.A.O
Tobacco use, only in males
Disease starts before 45 years.
Distal extremities involved first without embolic or atherosclerotic
features.
Absence of diabetes mellitus or hyperlipidaemia.
With or without thrombophlebitis.
Patient who are ready to participate and sig n the informed consent
form. |
|
| ExclusionCriteria |
| Details |
1. Cases of diabetes mellitus with peripheral neuropathies, cardiac
diseases, bleeding disorders, thrombocytopenia, any other severe
systemic diseases.
2. Chronic ulcers due to varicose veins |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
subjective parameters
Pain
Burning sensation
Sleep
Walking ability
Ulceration |
After completion of eaach 3 sittings of Jalaukavacharana i.e .1st ,4th and 6th day patients will be reviewed again. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pallor (Buerger’s test)
Boyd’s classification for intermittent
claudication.
Peripheral arterial pulse
Signs of ischemia
Edema. |
after completion of 3 sitting of Jalaukavacharana
patients will be reviewed again. |
|
|
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)
|
01/03/2016 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In Vatarakta Vata and Rakta obstruct movements of each other because of Avarana, so Raktamoshana(blood letting) is indicated to clear the channels and free movements of Vata and Rakta. Jalaukavacharana(leech therapy) one among Raktamokshana treatment is taken as treatment modality because Jalaukavacharana relives symptoms like different types of pain, burning sensation.it is also said that Jalaukavacharana is indicated in conditions where Rakta is clotted and deep seated. Aims and Objectives of the study To evaluate the efficacy of Jalaukavacharana in the management of Vatarakta (Buerger’s disease) Methedology Current study is open labeled, single arm, prospective clinical study with minimum 30 patients with pre and post test design. patient will be screened with the screening form which will be prepared with all aspects of history, sign and symptoms of Vatarakta(buerger’s disease), laboratory investigations to rule out major illness. After screening the patients of Vatarakta(buerger’s disease), will be recruited into the study. Jalaukavacharana will be done once in 2 days for 3sittings.(1st ,4th and 6th day) Total duration of treatment 7days. JAKAUKAVACHARANA:.(leech therapy) · Purva Karma(pre op procedure) · For patientThe patient is made either to sit or lie down, the area selected for application of Jalauka made rough by rubbing with either mud or fine powder of cow dung without causing pain. · For Jalauka(leech) the body of Jalauka should be smeared with solution of paste of Sarsapa and Haridra and kept in a water pot for a period of one Muhurta(28 minutes), the after knowing that they are free from fatigue it should be picked up and made to catch the place of the disease. · Pradhana Karma(operative procedure) Jalauka is to be applied on the site. Jalauka will bite on the skin and suck the blood itself. Its face appears like the hoof of a horse and it raises its neck by this we can understand that it has started sucking blood. As soon as Jalauka starts sucking, wet white gauze will be covered on it · Paschat Karma (post op procedure) After sucking Shuddha Rakta(pure blood) patient gets itching and pain at the site, then it is removed by sprinkling Haridra churna(turmeric powder ) at its mouth region and dressing will be done Follow up After completion of 3 sitting of Jalaukavacharana patients will be reviewed again.
|