| CTRI Number |
CTRI/2025/08/093601 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic medicines in the treatment of itching eruption in children and adults |
|
Scientific Title of Study
|
Efficacy of individualized homeopathic medicines in the treatment of scabies in children and adults: A double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1327-1660 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jahnabi Sardar |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Homeopathic Materia Medica, Room no- 12, PG-2. 12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9903842060 |
| Fax |
|
| Email |
sjahnabi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jahnabi Sardar |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Homeopathic Materia Medica, Room no- 12, PG-2. 12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9903842060 |
| Fax |
|
| Email |
sjahnabi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Arpita Basu |
| Designation |
Professor |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Homeopathic Materia Medica, Room no- 12, PG-2. 12 Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9830273374 |
| Fax |
|
| Email |
drarpitasen@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, 12 Gobinda Khathic Road, Tangra, Kolkata-700046, West Bengal |
|
|
Primary Sponsor
|
| Name |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
12 Gobinda Khathic Road, Tangra, Kolkata-700046, West Bengal |
| Type of Sponsor |
Government 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 Jahnabi Sardar |
D. N. De Homoeopathic Medical College and Hospital |
Dept. of Homoeopathic Materia Medica, OPD No- 12, PG-2, 12, Gobinda Khatick Road, Tangra, Kolkata-700046, West Bengal
Kolkata
WEST BENGAL |
9903842060
sjahnabi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D. N. De Homoeopathic Medical College and Hospital, 12 Gobinda Khatick Road, Tangra, Kolkata- 700046, West Bengal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B86||Scabies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical -looking placebo plus concomitant care |
This group will receive placebo, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue in empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Duration of therapy is 3 weeks. Both medicines and placebos will be re-packed in identical glass bottles and labelled with code, name of medicine, potency, and will be dispensed according to the random number list.Concomitant care includes, Treat all household members and close contacts at the same time as the infected person. Patients with an active scabies infestation should be immediately isolated to reduce spread. Wash all clothing and bedding used during the three days before treatment began. Items should be machine-washed using hot water, dried on the hot cycle, or dry-cleaned. Temperatures in excess of 50°C or 122°F for 10 minutes will kill mites and eggs. If you cant wash or dry clean an item, store it in a closed plastic bag for several days to a week to disinfect it. Scabies mites generally do not survive more than 2 – 3 days away from human skin. Children and adults can return to childcare, school, or work the day after treatment. Some study shows effectiveness of crude aloe vera gel in the treatment of scabies. The current study shows that, coconut seed extracts (CSE) have potential to prevent scabies. The extract from coconut seeds provides a safe, affordable, eco-friendly, and effective alternative to commercial medications used to control scabies that have detrimental effects on the health of human and animals. In recent years, the topical application of olive oil has been reported to be an effective option in treating pruritus. Plant derivatives such as turmeric, neem, and tea tree oil are also promising future treatments for scabies. |
| Intervention |
Individualized Homeopathic medicines plus concomitant care |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH/ RADAR software when required with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Provision will be kept to change the medicines or potencies and adjust the dosage in subsequent visits whenever required following the principles of classical homoeopathy and such instances will be compared between groups. Concomitant care includes, Treat all household members and close contacts at the same time as the infected person. Patients with an active scabies infestation should be immediately isolated to reduce spread. Wash all clothing and bedding used during the three days before treatment began. Items should be machine-washed using hot water, dried on the hot cycle, or dry-cleaned. Temperatures in excess of 50°C or 122°F for 10 minutes will kill mites and eggs. If you cant wash or dry clean an item, store it in a closed plastic bag for several days to a week to disinfect it. Scabies mites generally do not survive more than 2 – 3 days away from human skin. Children and adults can return to childcare, school, or work the day after treatment. Some study shows effectiveness of crude aloe vera gel in the treatment of scabies. The current study shows that, coconut seed extracts (CSE) have potential to prevent scabies. The extract from coconut seeds provides a safe, affordable, eco-friendly, and effective alternative to commercial medications used to control scabies that have detrimental effects on the health of human and animals. In recent years, the topical application of olive oil has been reported to be an effective option in treating pruritus. Plant derivatives such as turmeric, neem, and tea tree oil are also promising future treatments for scabies. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient suffering from scabies, and all household members and close contacts at the same time as the afflicted person.
2. Participants and/or guardians providing with written informed assent sand consent voluntarily.
3. Patients aged from 05-40 years.
4. Patients of either sex and transgender.
5. Clinical findings typical of scabies are burrows, erythematous papules, itching at night time, mite tunnels, macular or papular rashes with severe itching as main symptoms in web spaces, groin, other body parts, mite burrow in the webbed spaces of finger, flexor surface of wrist, elbows, axillae, belt line, feet, scrotum [male child], areolae [female child] etc.
6. Microscopic confirmation of scabies mite, ova, or mite faeces at classical sites by burrow ink test, KOH test and T-zanck smear. |
|
| ExclusionCriteria |
| Details |
1. Denying written informed consent / assent voluntarily.
2. Simultaneous participation in any other clinical trial.
3. Patients with known severe systemic illness, malignancy.
4. Participant with history of hypersensitivity reaction on any topical application.
5. Participant with other chronic disorders like juvenile diabetes, nephrotic syndrome, tuberculosis etc.
6. Associated with any other disease (immune-compromised state, AIDS, hepatitis etc.).
7. Secondary bacterial infection of scabies.
8. Norwegian scabies.
9. Cases of scabies in which the extent of an infestation cannot be reliably evaluated or cases where scabies co-exists with other skin diseases (e.g., atopic dermatitis, eczema, contact dermatitis, lichen planus, popular urticaria, seborrheic dermatitis) that may interfere with clinical assessment wise be excluded from the study.
10. The Skindex-29 score 26 and above.
11. Substance abuse and/or dependence.
12. Already undergoing homeopathic treatment for scabies or any other chronic diseases within last 2 months.
13. Patients who are too sick for consultation.
14. Pregnancy, puerperal women and lactating mother.
15. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life.
16. Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool). |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical cure: Improvement of lesions of scabies with no new lesions occurring since initiation of the treatment. |
At baseline, and after 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Skindex-29 questionnaire |
At baseline, every week, up to 3 weeks |
| Children Dermatology Life Quality Index (CDLQI) |
At baseline, every week, up to 3 weeks |
| Dermatology Life Quality Index (DLQI) |
At baseline, every week, up to 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="153"
Sample Size from India="153"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sjahnabi@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Scabies is caused by Sarcoptes scabiei var. hominis, a microscopic mite, spreads through direct skin to skin contact, is a highly contagious disease. In 2021, scabies contributes 5.3 million disability-adjusted life years (DALYs), which is a substantial contribution to the global burden of illness. In several Indian tribal populations, the prevalence of scabies is especially high, ranging from 6.9 to 20.6%. According to a 2010 study on dermatological diseases in Uttarakhand’s mountainous villages, 4.4% of people had scabies. The International Alliance for the Control of Scabies (IACS) has developed criteria to help with scabies diagnosis. Scabies can be effectively treated using topical and oral medications.Permethrin is much more effective and acceptable, but it is expensive and has several adverse effects. Despite the fact that homoeopathic drugs are widely used to treat scabies worldwide, there is still a lack of scientific studies to support their usage. In such conditions, we plan to conduct this study in order to assess the safety and efficacy of homeopathic remedies in the treatment of scabies. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 153 children and adults who are suffering from scabies at the outpatient’s department of D. N. De Homeopathic Medical College and Hospital. Assessment will be done by primary outcome measure which is to compare the proportion of participants revealing "clinical cure" that is disappearances of lesions of scabies and secondary measures (SKINDEX-29, CDLQI, and DLQI) are to detect the difference between the IHMs group and placebo group within 3 weeks of intervention. Group differences will be examined using appropriate statistical tests. The results will be published in scientific journals. |