| CTRI Number |
CTRI/2025/04/085129 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO STUDY THE EFFICACY OF HOMOEOPATHIC MEDICINE ECHINACEA ANGUSTIFOLIA IN THE MANAGEMENT OF CASES OF FURUNCLE |
|
Scientific Title of Study
|
TO STUDY THE EFFICACY OF HOMOEOPATHIC MEDICINE ECHINACEA ANGUSTIFOLIA IN THE
MANAGEMENT OF CASES OF FURUNCLE: A PROSPECTIVE INTERVENTIONAL SINGLE ARM 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 |
ANJANA VERMA |
| Designation |
PG SCHOLAR |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
ROOM NO 401, PG DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA, JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, WAGHODIA, VADODARA
Vadodara
GUJARAT
391760
India |
| Phone |
8799566782 |
| Fax |
|
| Email |
anjanaverma771@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DHWANI PARIKH |
| Designation |
BHMS, MD(HOM) |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
ROOM NO 402 A PG DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA, JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, WAGHODIA, VADODARA
Vadodara
GUJARAT
391760
India |
| Phone |
9033531879 |
| Fax |
|
| Email |
dhwani.parikh19393@parulunivery.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR DHWANI PARIKH |
| Designation |
BHMS, MD(HOM) |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
ROOM NO 402 A PG DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE WAGHODIA VADODARA
GUJARAT
391760
India |
| Phone |
9033531879 |
| Fax |
|
| Email |
dhwani.parikh19393@parulunivery.ac.in |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL PARUL UNIVERSITY, LIMDA, WAGHODIA, VADODARA, GUJARAT, 391760 |
|
|
Primary Sponsor
|
| Name |
ANJANA VERMA |
| Address |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL PARUL UNIVERSITY, LIMDA WAGHODIA, VADODARA, GUJARAT, 391760 |
| 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 ANJANA VERMA |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
OPD NO 110, DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA
Vadodara
GUJARAT |
8799566782
anjanaverma771@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Homoeopathic Medical College (Institutional Ethics Committee For Human Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L029||Cutaneous abscess, furuncle and carbuncle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ECHINACEA ANGUSTIFOLIA |
ECHINACEA ANGUSTIFOLIA WILL BE PRESCRIBED IN SELECTIVE POTENCY AS IN REQUIRED REPETITION FOR 3 DAYS OR WHEN IT IS REQUIRED |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients of both gender between 18 to 40 years of age.
2.All Socio-economic status.
3.Presence of one or more boils.
4.Patients willing to give informed consent |
|
| ExclusionCriteria |
| Details |
1.Presence of large boils greater than 5cm in diameter or in sensitive area i.e around nose, eyes, lips and genitalia.
2.Patient having severe pain, High grade fever greater than 38.5°C or signs of systemic infection i.e. sepsis.
3.Presence of immunosuppressive disorders i.e. HIV/AIDS, Cancer.
4.Pregnant or breastfeeding women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE THE EFFICACY OF ECHINACEA ANGUSTIFOLIA IN REDUCING THE SYMPTOMS AND DURATION OF FURUNCLES. |
2 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO STUDY THE EFFICACY OF ECHINACEA ANGUSTIFOLIA IN MANAGEMENT OF CASES OF FURUNCLE BY USING
FURUNCULOSIS SYMPTOMS SCORE(FSS).
INSIGNIFICANT IMPROVEMENT LESS THAN 25% |
2 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
03/06/2025 |
| 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 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 study is prospective interventional single arm trial to assess the effect of Echinacea Angustifolia in cases of Furuncle. The study will be conducted in 40 participants which will be enrolled in Jawaharlal Nehru Homoeopathic Medical College Hospital, Vadodara, Gujarat, India. Furunculosis Symptoms Score will be used for assessment purpose. The study will be conducted in the time duration of 1 year. |