| CTRI Number |
CTRI/2024/01/061660 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
10/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Chronic venous disease and Homoeopathy |
|
Scientific Title of Study
|
A clinical study to evaluate the response of the Homoeopathic treatment in Chronic Venous diseases(CVD) in the lower limbs |
| 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 Dastagiri |
| Designation |
Research officer Scientist 2 |
| Affiliation |
National Homoeopathy Research Institute in Mental health |
| Address |
National Homoeopathy Research Institute in Mental Health,
Under the Central Council for Research in Homoeopathy,
Ministry of AYUSH,
Kottayam,
Kerala.
Kottayam
KERALA
686532
India |
| Phone |
9000444409 |
| Fax |
0000 |
| Email |
drdastagirinhrimh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dastagiri |
| Designation |
Research officer Scientist 2 |
| Affiliation |
National Homoeopathy Research Institute in Mental health |
| Address |
National Homoeopathy Research Institute in Mental Health,
Under the Central Council for Research in Homoeopathy,
Ministry of AYUSH,
Kottayam,
Kerala.
Kottayam
KERALA
686532
India |
| Phone |
9000444409 |
| Fax |
0000 |
| Email |
drdastagirinhrimh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dastagiri |
| Designation |
Research officer Scientist 2 |
| Affiliation |
National Homoeopathy Research Institute in Mental health |
| Address |
National Homoeopathy Research Institute in Mental Health,
Under the Central Council for Research in Homoeopathy,
Ministry of AYUSH,
Kottayam,
Kerala.
Kottayam
KERALA
686532
India |
| Phone |
9000444409 |
| Fax |
0000 |
| Email |
drdastagirinhrimh@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health,
Under the Central Council for Research in Homoeopathy,
Ministry of AYUSH,
Kottayam,
Kerala. |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional area, D block, Janak puri, New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 Dastagiri |
National Homoeopathy Research Institute in Mental Health |
National Homoeopathy Research Institute in Mental Health,
Under the Central Council for Research in Homoeopathy,
Ministry of AYUSH,
Kottayam,
Kerala.
Kottayam
KERALA |
9000444409
0000
drdastagirinhrimh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee National Homoeopathy Research Institute in Mental Health |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic medicine |
The Individualised Homoeopathic medicine will be selected based on the signs and symptoms according to the Homoeopathic principles. The potency will be start from the 6c potency, repeated according the principles and gradually increase the potency as per the necessity of the case. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)all genders.
2)Visible varicose veins with varicose or stasis eczema, varicose ulcer, itching, pain or heaviness, swelling in the lower limbs,
3)Venous disease was diagnosed by duplex ultrasonography
|
|
| ExclusionCriteria |
| Details |
1)Pregnancy, lactation mother, secondary causes of chronic venous insufficiency or varicose veins (Abdominal tumors).
2)Any treatment for CVD over the last month.
3)If the Revised VCSS total score is between 25-30.
4)Participants who will not give consent for research
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved CVD and its complications and symptoms severity are assessed by grading systems using revised VCSS scores. |
baseline and monthly intervals for 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A decrease in CEAP rating.
Improvement in participant quality of life score as measured by validated, CIVIQ-14
Changes in reducing the size & healing of the varicose ulcer & varicose eczema evidenced by digital photography
Most commonly indicated homoeopathic medicines
|
baseline & monthly intervals for 12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/02/2024 |
| 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="2"
Months="6"
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
|
The presence of spider veins, varicose veins, oedema, skin hyperpigmentation, and venous ulcers in the affected areas characterizes the Chronic Venous Disease of lower limbs. Progressive venous insufficiency in a great saphenous vein (GSV) or small saphenous vein (SSV) is an underlying feature of these diseases. The condition of varicose veins has been defined as permanently dilated subcutaneous veins equal to or more than 3 mm in diameter in the upright position. Patients with varicose veins of the lower limbs typically present with abnormal sensation (itching, aching, tingling), leg pain, fatigue and heaviness, swelling, and restless leg syndrome with prolonged standing. These symptoms are associated with clinical signs, such as dilated tortuous veins (veins are twisted, swollen, and visible under the skin) and edema. Complications are leg ulcers, thrombophlebitis, and other pathological skin changes (e.g., Dermatitis) The present study has been designed to ascertain the response to Homeopathy treatment CVD and its complications using standard parameters for assessment. The clinical hypothesis is that individualized Homoeopathic treatments can significantly decrease CVD and its complaints like cramps, itching, tortuosity of veins, and skin complaints (eczema, ulcer) , when measured on standardized scales (measured with the CEAP classification, Revised Venous Clinical Severity Score (VCSS), and improve quality of life by CIVIQ-14 self-assessment questionnaire |