| CTRI Number |
CTRI/2025/09/095089 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of effectiveness of individualized homoeopathic medicine vis-a-vis combination of internal and external use of same homoeopathic medicine in management of Acne vulgaris. |
|
Scientific Title of Study
|
A prospective single blind randomized comparative clinical trial on effectiveness of individualized homoeopathic medicine vis-a-vis combination of internal and external use of same homoeopathic medicine in management of Acne vulgaris. |
| 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 Nikita Manik Bodke |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed to be university HMC post graduate and research center Pune |
| Address |
Bharati Vidyapeeth Deemed to be university HMC post graduate and research center Pune
Pune
MAHARASHTRA
411043
India
Bharati Vidyapeeth Deemed to be university HMC post graduate and research center,Dhankawadi,Satara road, Pune
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA
411043
India |
| Phone |
8329524070 |
| Fax |
|
| Email |
nikitamanikbodke@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinodini Patil |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be university HMC post graduate and research center Pune |
| Address |
Bharati Vidyapeeth Deemed to be university HMC post graduate and research center Dhankawadi, Satara Road,Pune
Pune
MAHARASHTRA
411043
India
Bharati Vidyapeeth Deemed to be university HMC post graduate and research center Dhankawadi, Satara Road,Pune
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA
411043
India |
| Phone |
9890127840 |
| Fax |
|
| Email |
vinodini.patil@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Manik Bodke |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed to be university HMC post graduate and research center Pune |
| Address |
Bharati Vidyapeeth Deemed to be university HMC post graduate and research center Dhankawadi, Satara Road,Pune
Pune
MAHARASHTRA
411043
India
Bharati Vidyapeeth Deemed to be university HMC post graduate and research center Dhankawadi, Satara Road,Pune
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA
411043
India |
| Phone |
8329524070 |
| Fax |
|
| Email |
nikitamanikbodke@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed to be university homoeopathic medical college and homoeopathic hospital department of post graduate and research center Pune |
|
|
Primary Sponsor
|
| Name |
Dr Nikita Manik Bodke |
| Address |
Bharati Vidyapeeth Deemed to be university homoeopathic medical college and homoeopathic hospital department of post graduate and research center Pune |
| 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 Nikita Manik Bodke |
Bharati Vidyapeeth Deemed to be university Homoeopathic college and hospital |
Bharati Vidyapeeth Deemed to be university HMC post graduate and research center Dhankawadi, Satara Road,Pune
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA |
08329524070
nikitamanikbodke@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed to be university homoeopathic medical college and homoeopathic hospital department of post graduate and research center Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L988||Other specified disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicine |
Individualized Homoeopathic medicine after detail case taking, dose and repetition depending upon case itself |
| Comparator Agent |
Internet and external same homeopathic medicine |
Internet and external same homeopathic medicine after detail case taking, dose and repetition depending upon case itself |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1-Age :18-35 years
2-Both sexes
3-Diagnosed cases of acne vulgaris
4-Patients giving voluntary consent for study
5-Acne score 1-18 mild, 19-30 moderate.
|
|
| ExclusionCriteria |
| Details |
1-Pregnant females and female who are lactating will be excluded.
2-Patient suffering from any systemic illness requiring conventional treatment.
3-Patient with nodulocystic acne.
4-Acne scores 31-39 severe to very severe will be excluded.
5-Patient with advanced pathological conditions and immunocompromised patients.
6-Current use of other acne treatment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the AGAS score after the intervention of homoeopathic medicines. |
From baseline to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduce intensity of acne can be graded using validated GAGS with using IHM VS internal and external same Hom Med
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
30/09/2025 |
| 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
|
Acne vulgaris is chronic inflammatory disorder of pilosebaceous unit Acne vulgaris is most common type of acne in adolescence and young adult Incidence peaks at teenagers but women and men between 20 35yrs of age also affected Acne vulgaris classified into four grades Grade1 Comedones and occasionally papules Grade 2 Papules Comedones and few pustules Grade 3 Predominant pustules occasionally nodules and abscesses Grade 4 Mainly cysts abscesses and widespread scarring Homoeopathy with its individualized and holistic approach offer potential as a safe complementary treatment A prospective single blind randomized comparative clinical trial on effectiveness of Individualized homoeopathic medicine vs the combination of internal and external same homoeopathic medicine in reducing severity and number of acnes vulgaris lesions in individuals aged 18 35 years |