| CTRI Number |
CTRI/2025/03/081989 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effects of homoeopathic medicines in cases of Acne in adults |
|
Scientific Title of Study
|
Prospective interventional study to ascertain the effectiveness of homoeopathic medicines in cases of acne in adults by using GAGS scale
|
| 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 Digna Solanki |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of practice of medicine, Rajkot Homoeopathic Medical college, behind jainath complex, makkam chowk, gondal road, rajkot.
Rajkot
GUJARAT
360002
India |
| Phone |
8849318212 |
| Fax |
|
| Email |
dignasolanki26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Urmila Bhalgariya |
| Designation |
Assistant Professor |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Practice of Medicine, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Gondal road, rajkot.
Rajkot
GUJARAT
360002
India |
| Phone |
9409249004 |
| Fax |
|
| Email |
urmila.bhalgariya22665@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Digna Solanki |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Practice of medicine, Rajkot Homoeopathic medical College, behind jainath complex, makkam chowk, Gondal road, rajkot.
Rajkot
GUJARAT
3600002
India |
| Phone |
8849318212 |
| Fax |
|
| Email |
dignasolanki26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College Attached With Sainath Hospital, Parul University, Rajkot, Gujrat, india-360002 |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic Medical College Attached with Sainath Hospital |
| Address |
Rajkot Homoeopathic Medical college, behind jainath complex, makkam chowk, gondal road, Rajkot |
| Type of Sponsor |
Private medical college |
|
|
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 Digna Solanki |
Rajkot Homoeopathic Medical College Attached with sainath hospital, parul university |
Department of practice of medicine, rajkot homoeopathic medical college ,behind jainath complex, makkam chowk,gondal road, rajkot-360002
Rajkot
GUJARAT |
8849318212
dignasolanki26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research - Rajkot Homoeopathic Medical College(RHMC), Parul university |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L709||Acne, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicine |
Individualized homoeopathic medicine. Mode of administration:oral(sublingual) selection of potency, dose and repetition: individualized medicine will be prescribed in 30,200,1 M potency. selection of dosage, potency and repetition will be according to susceptibility of patient and principles of organon of medicine.duration- 9 months |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Both sexes male and female included.
Only those Patients are included who are Clinically manageable.
Cases will be selected on diagnostic criteria mainly done on basis of clinical history presentation and examination finding or pre diagnosed cases of acne.
All socio-economical classes are considered.
|
|
| ExclusionCriteria |
| Details |
Patients with serious pathological conditions, Genetic disorders, autoimmune diseases, life threatening conditions.
Patients above 35 years and below 19 years of age.
Patients with other skin diseases with same manifestation.
Patients taking other therapeutic measures for Acne and other skin diseases.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| There will be some improvement after prescribing Homoeopathic medicines |
There will be some improvement after prescribing Homoeopathic medicines after 6-8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Cure-When total score is 0, patient with sense of well-being without any complaints & disappearance of all the symptoms with no relapse or recurrence of symptoms.
•Improvement- A significant reduction in the GAGS score, indicating an amelioration of clinical symptoms.
•No improvement / status quo – there is no considerable change in any symptoms.
|
There will be some improvement after prescribing Homoeopathic medicines after 9 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 2 |
|
Date of First Enrollment (India)
|
16/07/2025 |
| 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="0"
Months="9"
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
|
Acne is a disorder of the pilosebaceous apparatus characterized by comedones, papules, pustules, cysts and scars the condition commonly manifests on the face, although it can also affect the upper arms, trunk, and back.Adult acne is classified into three groups within itself. It starts in adolescence period and continues, it is called ‘‘persistent acne’’ while if it develops for the first time after the age of 25 it is called ‘‘late-onset acne’’. Lastly, ‘‘relapsing acne’’ is used for acne which heals and continues in attacks from the young to adult age. Acne is one of the most prevalent inflammatory skin diseases. Epidemiological data have disclosed that, on a global scale, it is the eighth most frequent disease, with 9.4% predominance, including both adults and adolescents of several ethnic groups. 83% percent exacerbation with menses, 67% with stress, and 26% by diet. Pregnancy affected acne in 65% of the women, with 41% reporting improvement and 29% reporting worsening with pregnancy. As per large survey on acne issues among Indians in 2019, by age group- Among them 10.12% were teens (below 19 years),12.36% young adults (20-29 years),7.74% adults (30-44 years),3.37% older adults (45-59 years),2.5% seniors (60 years and above).Acne is usually recognized as adolescent skin disorder but prevalence of adult acne is increasing. Despite the increasing prevalence of adult acne there is lacking of practical guidelines, lack of data on prevalence, well document studies.
Despite advancements in conventional medical treatments, some patients may experience adverse effects. Topical Allopathic medicines like antibiotics, retinoids, benzoyl peroxide, salicylic acid, clindamycin causes most common side effects like skin dryness and irritation. side effects for oral medications can be more serious. Antibiotics can give you an upset stomach or make you dizzy and lightheaded. Hormonal pills can cause massive side effects. Now a days laser treatment for acne is on trending among youngsters, but it causes more damage of skin, it is not permanent solution but rising of other worsening conditions. It takes much time and also not pocket friendly.
Homeopathy is known for its holistic approach to patient considering individual symptoms, lifestyle, and emotional well-being. Examining the holistic aspects of homeopathic treatments may contribute to a more comprehensive understanding of managing acne in adults. Homoeopathic medicines having marvelous results on hormonal imbalance, stress management, decreases relapsing of acne. Homeopathy can effectively counter all possible causes of acne and fix this condition from the root. Homoeopathic individualized medicine can treat acne according to its cause.
The study seeks to evaluate not only the physiological changes but also patient-reported outcomes, considering factors such as quality of life, energy levels, and emotional well-being. Understanding these patient-centric outcomes will contribute to a more comprehensive assessment of the overall effectiveness of homeopathic interventions. In conclusion, there is a compelling need for this study to address the rising incidence of acne in adults, overcome limitations in current approaches, and provide a more holistic perspective on patient care. The use of established scales will ensure a rigorous evaluation of the efficacy of homeopathic interventions in treating acne. Research question Whether the patient suffering from acne will get beneficial result after taking homoeopathic medicines? Hypothesis: Ø Null Hypothesis (H0): - There will be no improvement after prescribing individualized Homoeopathic medicine.
Ø Alternative Hypothesis (H1): - There will be improvement in symptoms after individualized Homoeopathic medicine prescribing.
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