| CTRI Number |
CTRI/2024/08/072431 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of leech therapy along with Patolakaturohinyadi Kashaya internally and washing with triphala kashaya externally in Varicose Eczema |
|
Scientific Title of Study
|
Clinical study to evaluate the effect of Jalaukavacharana along with Patolakaturohinyadi kashaya and Triphala kashaya kshalana in Varicose eczema |
| 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 N Madhuri Devi |
| Designation |
HOD Department of Shalyatantra |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and Post Graduate Center |
| Address |
Department of Shalyatantra
Pankajakasthuri Ayurveda Medical College and Post Graduate Center
Kattakada
Thiruvananthapuram
Kerala
695572
India
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447743331 |
| Fax |
|
| Email |
drmadhurisreyas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kaveri S |
| Designation |
PG Scholar |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and Post Graduate Center |
| Address |
Department of Shalyatantra
Pankajakasthuri Ayurveda Medical College and Post Graduate Center
Kattakada
Thiruvananthapuram
Kerala
695572
India
Thiruvananthapuram
KERALA
695505
India |
| Phone |
6282363504 |
| Fax |
|
| Email |
kaverisekharan5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kaveri S |
| Designation |
PG Scholar |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and Post Graduate Center |
| Address |
Department of Shalyatantra
Pankajakasthuri Ayurveda Medical College and Post Graduate Center
Kattakada
Thiruvananthapuram
Kerala
695572
India
Thiruvananthapuram
KERALA
695505
India |
| Phone |
6282363504 |
| Fax |
|
| Email |
kaverisekharan5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pankajakasthuri Ayurveda Medical College and Postgraduate Center
Kattakada
Thiruvananthapuram
Kerala
Pin 695572 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Kaveri S |
Pankajakasthuri Ayurveda Medical College and PG Center |
OP Department of Shalyatantra, Room number: H 04
Thiruvananthapuram
KERALA |
6282363504
kaverisekharan5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC) Pankajakasthuri Ayurveda Medical College and PG Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I838||Varicose veins of lower extremities with other complications. Ayurveda Condition: SIRAJAGRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | jalaukAvacaraNam | (Procedure Reference: Susrutha Samhitha Sutrasthana,13th chapter, 6th verse, Procedure details: Pre-operative Procedure
Jalauka with average size & weight will be selected for the procedure and it will be taken and kept in water added with Haridra Choornam and also in plain water till these Jalauka get activated and thus it will be kept ready for the procedure. Informed consent will be taken. Vital signs and blood test will be checked and recorded. Patient will be positioned comfortably. The area will be identified and cleaned for procedure. Operative procedure
Jalauka will be applied over the affected area. When the Jalauka attaches to the site, it will be covered with wet cotton. Jalaukavacharana will be done until Jalauka is removed by itself or by application of turmeric powder on the mouth of leech after 1 hour.
Post–operative Procedure
Sterile dressing will be done at the site of bite. The Jalaukas are made to vomit off the sucked blood. Later the vomited Jalaukas are cleaned in turmeric water and kept in fresh water bottles.)
(1) Medicine Name: Patolakaturohinyadi Kashayam, Reference: Ashtanga Hridaya Sutrasthana 15th chapter, 15th verse, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 48(ml), Frequency: bd, Duration: 21 Days(2) Medicine Name: Triphala Kashaya, Reference: Bhavaprakasha Haritakyadi varga 42nd and 43rd verse, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of age group between 30-70 years irrespective of gender, religion, occupation and socio-economic status.
2. Subjects with signs and symptoms of Varicose eczema.
3. Subjects willing to sign the consent form |
|
| ExclusionCriteria |
| Details |
1. Subjects using anticoagulants and blood thinners.
2. Subjects having uncontrolled Diabetes Mellitus.
3. Subjects contraindicated for Rakthamokshana
4. Pregnant and lactating women. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the effect of Jalaukavacharana along with Patolakaturohinyadi kashaya internally and Triphala kashaya kshalana in the management of Varicose eczema.
2. To find out the effect of Jalaukavacharana along with Patolakaturohinyadi kashaya internally and Triphala kashaya kshalana in reducing signs and symptoms of Varicose eczema using Patient-Oriented Eczema Measure (POEM).
3. To evaluate the effect of Jalaukavacharana along with Patolakaturohinyadi kashaya internally and Triphala kashaya kshalana in improving quality of life in Varicose Eczema using Dermatology life quality index (DLQI).. |
1. Clinical assessment of signs and symptoms of Varicose eczema will be done on 0th, 11th, 21st and 30th day.
Follow up will be done on 30th and 45th day.
2. Assessment of severity of Varicose eczema in an individual using Patient-Oriented Eczema Measure (POEM) on 0th, 11th, 21st and 30th day.
2. Assessment of the quality of life in an individual
using Dermatology Life Quality Index (DLQI) on 0th, 11th, 21st and 30th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the safety of Jalaukavacharana in subjects with Varicose eczema.
Haemoglobin & Erythrocyte Sedimentation Rate will be done to assess the safety. |
Safety parameters will be assessed on 1st & 21st day |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
19/08/2024 |
| 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)
|
Not Applicable |
| 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
|
CLINICAL STUDY TO EVALUATE THE EFFECT OF JALAUKAVACHARANA ALONG WITH PATOLAKATUROHINYADI KASHAYA AND TRIPHALA KASHAYA KSHALANA IN VARICOSE ECZEMA Skin diseases are the most common problem worldwide. Varicose Eczema is such an ailment which causes psychological, social and financial burden on patient and their families. It is a condition usually present secondary to varicose vein. There will be skin changes in lower limb as a result of stasis or pooling by gravitational collection of blood from insufficient venous return. Objective of the study is to find the effect of Jalaukavacharana along with Patolakaturohinyadi kashaya and Triphala kashaya kshalana in reducing the signs and symptoms of Varicose Eczema. Here the study designed as an interventional clinical trial without control group. All 32 subjects in this study will be given three sittings of Jalaukavacharana on 1st, 11th and 21st day along with medications for a period of 21 days.
Medications include Patolakaturohinyadi kashaya 48 ml internally in morning and evening before food. Daily kshalana of the affected area will be done with Triphala kashaya. Assessments will be done before and after treatment. Results will be analyzed statistically and conclusion will be drawn. |