| CTRI Number |
CTRI/2025/09/094914 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to test the effect of homoeopathic medicines in treating varicose veins |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in the treatment of varicose veins - a randomized placebo controlled trial |
| 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 Meenakshi Gupta |
| Designation |
PG Trainee |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute |
| Address |
Department of Practice of Medicine, Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute, Sri Ganganagar, Rajasthan
Tantia University Campus, Near RIICO Bus Stand, Hanumangarh Road, Sri Ganganagar, Rajasthan 335002
Ganganagar
RAJASTHAN
335002
India |
| Phone |
9456848114 |
| Fax |
|
| Email |
angelmini2810@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Aggarwal |
| Designation |
Professor and Head |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute |
| Address |
Department of Practice of Medicine, Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute, Sri Ganganagar, Rajasthan
Tantia University Campus, Near RIICO Bus Stand, Hanumangarh Road, Sri Ganganagar, Rajasthan 335002
Ganganagar
RAJASTHAN
335002
India |
| Phone |
9929319610 |
| Fax |
|
| Email |
aggarwal.anil1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenakshi Gupta |
| Designation |
PG Trainee |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute |
| Address |
Department of Practice of Medicine, Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute, Sri Ganganagar, Rajasthan
Tantia University Campus, Near RIICO Bus Stand, Hanumangarh Road, Sri Ganganagar, Rajasthan 335002
RAJASTHAN
335002
India |
| Phone |
9456848114 |
| Fax |
|
| Email |
angelmini2810@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ganganagar Homeopathic Medical College Hospital And Research Institute, Sri Ganganagar, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Dr Meenakshi Gupta |
| Address |
Department of Practice of Medicine, Sri Ganganagar Homoeopathic Medical College, Hospital and Research Institute, Tantia University Campus, Near RIICO Bus Stand, Hanumangarh Road, Sri Ganganagar, Rajasthan. PIN-335002 |
| Type of Sponsor |
Other [Self] |
|
|
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 Meenakshi Gupta |
Sri Ganganagar Homoeopathic Medical College, Hospital and Research Institute |
Surgery OPD, Room No. 101, SGHMCHRI, Tantia University campus, Near RIICO Bus Stand, Hanumangarh Rd, Sri Ganganagar, Rajasthan 335002
Ganganagar
RAJASTHAN |
09456848114
angelmini2810@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Ganganagar Homoeopathic Medical College, Hospital and Research Institute, Sri Ganganagar, Rajasthan, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I83||Varicose veins of lower extremities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicines |
Based on severity and totality of each patients specific symptoms, followed by consultation of symptoms with Materia Medica and repertorial analysis, treatment decision will be taken and individualised (personalised) homoeopathic medicine will be selected for the treatment of varicose veins in that patient.
Route of drugs administered will be oral, in form of inert sucrose globules (pellets) impregnated with active drug in suitable packing/container.
Dose and frequency of drug selected may vary and will depend upon potency indicated of each individual drug and severity of patients symptoms. |
| Comparator Agent |
Placebo |
As per indicated in Organon of Medicine, oral inert sucrose globules (pellets) impregnated with hydro-ethanolic solution (without any active ingredient) will be dispensed, with appearance and container/packing matching to active drugs (dispensed in intervention group). Dose and frequency of placebo may vary and will depend upon the severity of patients symptoms. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed patients with varicose veins, patients willing to participate in study and providing written informed consent |
|
| ExclusionCriteria |
| Details |
Associated comorbidities: Patients with associated medical conditions like any severe systemic illness, chronic communicable/non-communicable diseases, moderate to severe acute infectious condition, or any organ failure; Any vascular conditions that may impact findings of study including e.g. Atherosclerosis, Deep Vein Thrombosis, history of CVA, Peripheral Artery Disease, or any hypercoagulable state; Patients with the history of taking any medication for varicose veins within a period of 2 weeks before starting study; Special Population: Pregnant and lactating women, paediatric and geriatric patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms of varicose veins and quality of life of patients |
After inclusion, patients will be followed-up preferably after 2 weeks, 1 month, 2 months and 3 months from inclusion, as and when required. Patients visits may vary depending upon individualized therapy and patients clinical condition, except final visit at 3 months. VCSS scale and AVVQ questionnaire will be applied at the time of inclusion and at the completion of follow-up period, i.e., 3 months. Changes in symptomatology and scores will be noted and analysed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identify most frequently used homoeopathic medicines in treating varicose veins |
At inclusion, patient clinical condition will be analysed & individualized homoeopathic medicines or placebo will be prescribed to the subject for varicose veins. Frequency of each drug prescribed in study will be analysed to find out drugs frequently used drugs to treat varicose veins. After inclusion, patients will be followed-up preferably after 2 weeks, 1 month, 2 months & 3 months from inclusion, as & when required depending upon individualized therapy & patients clinical condition. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/10/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Varicose veins are a common chronic venous disorder associated with pain,
swelling, heaviness, and cosmetic concerns. Conventional treatments include
compression therapy, sclerotherapy, and surgery, but these approaches may have
limitations, recurrence, or side effects. This randomized placebo-controlled
trial aims to evaluate the efficacy of individualized homoeopathic medicines in
improving symptoms and quality of life of patients with varicose veins.
Eligible participants will be randomized to receive either individualized
homoeopathic medicines or placebo over a specified treatment duration, and
outcomes will be assessed using standardized clinical parameters and validated
quality-of-life questionnaire. |