| CTRI Number |
CTRI/2025/02/080617 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic Treatment of Warts |
|
Scientific Title of Study
|
Efficacy of Homoeopathic Medicines of Materia Medica Pura in Warts a Single Blind Randomized 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 Arpita Priyadarsini |
| Designation |
Post Graduate Trainee |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department of Homoeopathic Materia Medica State National Homoeopathic Medical College And Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7077977996 |
| Fax |
|
| Email |
arpita7077977996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reshma Chandrabhanji Hiwrale |
| Designation |
Lecturer Department of Homoeopathic Materia Medica |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department of Homoeopathic Materia Medica State National Homoeopathic Medical College And Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9473854481 |
| Fax |
|
| Email |
rhreshma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arpita Priyadarsini |
| Designation |
Post Graduate Trainee |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department of Homoeopathic Materia Medica State National Homoeopathic Medical College And Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
07205520567 |
| Fax |
|
| Email |
arpita7077977996@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow 226010 Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
Dr Arpita Priyadarsini |
| Address |
Department of Homoeopathic Materia Medica State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow 226010 Uttar Pradesh
India |
| 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 Arpita Priyadarsini |
State National Homoeopathic Medical College and Hospital |
OPD NO 2 State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar
Lucknow
UTTAR PRADESH |
07077977996
arpita7077977996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow 226010 Uttar Pradesh India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B079||Viral wart, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Globules of cane sugar as placebo |
Another group of 41 patient suffering from warts will be receive 4-6 similar looking placebo globules of cane sugar with no medicinal value the study duration will be 18 months |
| Intervention |
Individualized Homoeopathic Medicine |
Intervention is planned as administering individualized homoeopathic medicine to a group of 41 patients suffering from warts after proper case taking individualized homoeopathic medicines of Materia Medica pura will be given according to homoeopathic posology. Each dose shall consist of 4-6 globules of cane sugar medicated with single medicine to be taken in an empty stomach The study duration will be 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with any type of warts
Patients who are able to provide informed consent and comply with the study requirements
Patients with no history of homoeopathic medication in the past four months. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Patients with a past history of organ transplant surgery
Patients with a past history of skin cancer Patients already diagnosed as HIV positive Patients with advanced disease of vital organs Patients under any individualized homoeopathic medication
Idiosyncratic patients
Hypochondriac patients
Patient from foreign country |
|
|
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 |
| Changes in Dermatological Life Quality Index in cases of warts |
3 months to 6 months from base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of homoeopathic medicines of Materia Medica Pura and Placebo in treatment of warts |
3 months to 6 months from base line |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
25/02/2025 |
| 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="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
|
This is a prospective single blind randomized parallel group placebo-controlled trial which aims is to assess and compare the efficacy of homoeopathic medicines of Materia Medica Pura and placebo in the treatment of warts. Warts are the common medical problems. In Homoeopathy, removing the local symptom through external application without addressing the internal disease is considered problematic. Such methods are described as “criminal” since they suppress the symptoms, leaving the underlying disease untreated. Homoeopathy involves the use of powerful internal medicines to eliminate the internal disease, ensuring a complete and lasting cure. Also there has been limited research focusing on the treatment of warts using medicines documented in Materia Medica Pura. therefore, I intend to undertake this trial to research in this particular domain. The study will be conducted for a period of 18 months. Target sample size will be 68 but considering 20% dropout case total 82 patient need to be enrolled. All patients will be enrolled according to the inclusion and exclusion criteria. Cases will be diagnosed based on location, shape, and size of the wart’s diameter, size and length of wart will be measured by vernier caliper. A proper homoeopathic case taking proforma will be used to individualize the case. Patients will be randomized to receive either individualized homoeopathic medicine from Materia Medica Pura (n=41) or placebo (n=41). Group A- will receive individualized homoeopathic medicines of Materia Medica Pura. Group B- will be receive similar looking placebo globules. Globules will be administered orally to the patients. Doses and potency will be selected according to homoeopathic posology as described in Organon of medicine. Patients will be called for follow-up every 15 days, with the final assessment done in 3 months from the baseline. Follow-up will be recorded using DLQI. Status of warts will be recorded by using vernier Caliper (Measuring Scale) to show changes in size and dimension of warts. Expected Outcomes: Reduction in numbers and size of warts, Changes in Dermatological Life Quality Index (DLQI), Reevaluation of Materia Medica Pura in the treatment of warts, and to compare the efficacy of homoeopathic medicines of Materia Medica Pura and placebo in the treatment of warts. |