| CTRI Number |
CTRI/2024/12/077646 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Homoeopathic Medicines in cases of Varicose Veins. |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Medicines in the Management of Chronic Venous Diseases: An Exploratory Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Laviza Arzoo |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College And Hospital |
| Address |
Department Of Homoeopathic Materia Medica
Room no S1
Second floor
Bakson Homoeopathic Medical College And Hospital
36 B Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
6005921996 |
| Fax |
|
| Email |
laviza.a98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Nair |
| Designation |
PG Incharge, HOD Department of Materia medica |
| Affiliation |
Bakson Homoeopathic Medical College And Hospital |
| Address |
Post Graduation Cell Room no G21 Ground Floor
Bakson Homoeopathic Medical College And Hospital
36 B Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9990178024 |
| Fax |
|
| Email |
pginchargebakson@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Nair |
| Designation |
PG Incharge, HOD Department of Materia medica |
| Affiliation |
Bakson Homoeopathic Medical College And Hospital |
| Address |
Post Graduation Cell Room no G21 Ground Floor
Bakson Homoeopathic Medical College And Hospital
36 B Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9990178024 |
| Fax |
|
| Email |
pginchargebakson@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Bakson Homoeopathic Medical College And Hospital
36 B Knowledge Park 1
Greater Noida |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no G22
Ground Floor
Bakson Homoeopathic Medical College And Hospital
36 B Knowledge Park 1
Greater Noida. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Laviza Arzoo |
Bakson Homoeopathic Medical College And Hospital |
Out Patient Department(OPD)Room no 1 Ground Floor Bakson Homoeopathic Medical College And Hospital
36B Knowledge Park 1
Greater Noida
201310
Gautam Buddha Nagar
UTTAR PRADESH |
6005921996
laviza.a98@gmail.com |
| Dr Laviza Arzoo |
Dr D P Rastogi Central Research Institute Of Homoeopathy |
Out Patient Department
(OPD) Room No 110
Ground Floor A 1/1
Sector 24 Noida
201301
Gautam Buddha Nagar
UTTAR PRADESH |
6005921996
laviza.a98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bakson Institutional Ethical Committee. |
Approved |
| Kendriya Homoeopathy Anusandhan Parishad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I872||Venous insufficiency (chronic) (peripheral), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Oral route of administration pill form
30 number pill size centesimal scale
First dose after case taking and subsequent doses after each follow up and potency according to the case |
| Comparator Agent |
NIL |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
Participants presented between C0 and C6 according to CEAP clinical rating.
Participants presenting with visible varicose veins with varicose or stasis eczema, varicose ulcers, itching, pain, heaviness, numbness, and swelling in lower limbs.
Age above 18
All genders.
|
|
| ExclusionCriteria |
| Details |
Pregnancy, lactating mother, secondary causes of chronic venous disease or varicose veins (abdominal tumors).
Any participants presenting with deep vein thrombosis, thrombophlebitis, severe systemic illness, immunocompromised, under the influence of substance abuse, and any psychiatric illness.
Participants who need surgical intervention.
Participants who refuse to give consent.
Participants who are under any other sort of treatment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in total score of Revised VCSS will signify improvement in signs and symptoms of chronic venous disease. |
Revised Venous clinical severity score will be evaluated at Baseline, 4 weeks, 8
weeks, 12 weeks till 24 weeks
Study Duration 15 months
Enrollment period (6 months)
Follow-up duration (6 months)
Data analysis and report writing (3 months)
First dose will be given after case taking and
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in participant quality of life score as measured by validated CIVIQ-20.
|
Quality of life assessment will be done using the CIVIQ-20 questionnaire at Baseline, 4 weeks, 8 weeks, 12 weeks till 24 weeks
Study Duration 15 months
Enrollment period (6 months)
Follow-up duration (6 months)
Data analysis and report writing (3 months)
|
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2024 |
| 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
|
This exploratory study aims to evaluate the effectiveness of individualized homoeopathic medicines in the management chronic venous diseases. The duration of the study is 15 months. Participants will be screened and enrolled as per the inclusion and exclusion criteria. The expected outcome is significant improvement in the signs and symptoms of chronic venous disease by measuring changes in the CEAP clinical rating, the Revised Venous Clinical Severity Score (VCSS), and the quality of life of patients using CIVIQ-20, both before and after treatment. The result will be concluded accordingly.
|