| CTRI Number |
CTRI/2026/01/101480 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to understand how homoeopathic treatment and addressing factors related to lifestyle that act as obstacles to cure help improve dry skin of the soles in people aged 40 to 70 years assessed using the Overall Dry Skin Score and the Dermatology Life Quality Index |
|
Scientific Title of Study
|
A Clinical Study On The Efficacy Of Homoeopathic Management Addressing Obstacles To Cure Related To Lifestyle In Cases Of Plantar Xerosis Cutis In Age Group 40 To 70 Years Using The Overall Dry Skin Score And Dermatology Life Quality Index |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Namrata Jani |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Homoeopathy and Research Hospital |
| Address |
Parul Institute of Homoeopathy and Research, Room 403, 3rd floor Department of Organon of Medicine and Homoeopathic Philosophy, At. Ishwarpura, PO. Limda, TA. Waghodia, DI. Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8347249299 |
| Fax |
|
| Email |
namratajani1299@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vibhuti Amol Pathak |
| Designation |
Professor |
| Affiliation |
Parul Institute of Homoeopathy and Research Hospital |
| Address |
Parul Institute of Homoeopathy and Research, Room 403, 3rd floor Department of Organon of Medicine and Homoeopathic Philosophy, At. Ishwarpura, PO. Limda, TA. Waghodia, DI. Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9890520965 |
| Fax |
|
| Email |
vibhuti.kulkarni@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Namrata Jani |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Homoeopathy and Research Hospital |
| Address |
Parul Institute of Homoeopathy and Research, Room 403, 3rd floor Department of Organon of Medicine and Homoeopathic Philosophy, At. Ishwarpura, PO. Limda, TA. Waghodia, DI. Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8347249299 |
| Fax |
|
| Email |
namratajani1299@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Homoeopathy and Research |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Homoeopathy and Research |
| Address |
Parul Institute of Homoeopathy and Research, At. Ishwarpura, PO. Limda, TA. Waghodia, DI. Vadodara - 391760 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Namrata Jani |
Parul Institute of Homoeopathy and Research, At. Ishwarpura, PO. Limda, TA. Waghodia, DI. Vadodara - 391760 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Namrata Jani |
Parul Institute of Homoeopathy and Research Hospital |
Parul Institute of Homoeopathy and Research, Room 403, 3rd floor Department of Organon of Medicine and Homoeopathic Philosophy, At. Ishwarpura, PO. Limda, TA. Waghodia, DI. Vadodara - 391760
Vadodara
GUJARAT |
8347249299
namratajani1299@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L853||Xerosis cutis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicine |
The intervention in this study is individualized (single medicine) homoeopathic treatment for patients with plantar xerosis cutis. Instead of giving the same medicine to all patients, treatment is given to each patient based on complete clinical evaluation. This evaluation includes the appearance and condition of the skin of the soles, general health status, factors related to lifestyle and mental and emotional characteristics. The aim of the intervention is to manage plantar xerosis cutis by selecting a medicine that best matches all the symptoms of the patient and by addressing factors that may interfere with recovery. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals of all socio-economic backgrounds.
Willingness to participate in the study and provide informed consent.
Individuals not under any other medications. |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women.
Presence of systemic illnesses.
Use of topical or systemic steroids in the last 3 months.
Presence of active foot ulcers, secondary infections, or other dermatological conditions in the lower limbs.
Individuals under any other medications. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement in clinical severity using the Overall Dry Skin Score (ODSS) and quality of life using the Dermatology Life Quality Index (DLQI) before and after individualized homeopathic treatment in cases of plantar xerosis cutis. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To address obstacles to cure related to lifestyle in cases of plantar xerosis cutis in individuals aged 40 to 70 years. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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) |
Open to Recruitment |
|
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 study is a clinical study to evaluate the efficacy of individualized homoeopathic treatment in the management of plantar xerosis cutis in individuals aged 40 to 70 years and to assess the role of factors related to lifestyle acting as obstacles to cure. The study will be conducted at Parul Institute of Homoeopathy and Research Hospital, Vadodara with a total sample size of 30 patients and a treatment duration of 3 months. Each patient will receive individualized (single medicine) homoeopathic treatment based on detailed clinical assessment including the appearance and condition of skin of soles, general health status, lifestyle factors and mental and emotional factors. The primary outcome of the study will be the improvement in clinical severity and quality of life of patients with plantar xerosis cutis which will be assessed using the Overall Dry Skin Score (ODSS) and the Dermatology Life Quality Index (DLQI) before and after treatment. The secondary outcome will be the assessment of factors related to lifestyle acting as obstacles to cure and their influence on treatment outcomes during the study period. |