| CTRI Number |
CTRI/2025/11/097220 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
“A Study on the Role of Individualised Homoeopathic Medicines in Regression of Precancerous Cervical Changes among Women in Kanniyakumari District” |
|
Scientific Title of Study
|
Evaluation of effectiveness of individualized homoeopathic medicine in the regression of cervical premalignant lesion of women in kanniyakumari district, a single arm clinical interventional study. |
| Trial Acronym |
HER-C Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Girija L |
| Designation |
Associate Professor |
| Affiliation |
Dr. L. Girija, Associate Professor, College Building, 3rd Floor, Room No. 402, Department of Obstetrics and Gynaecology, Sarada Krishna Homoeopathic Medical College |
| Address |
Sarada Krishna Homoeopathic Medical College, College Building, 3rd Floor, Room No. 402, Department of Obstetrics and Gynaecology, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumaari District.
Sarada Krishna Homoeopathic Medical College, College Building, 3rd Floor, Room No. 402, Department of Obstetrics and Gynaecology, Sarada Krishna Homoeopathic Medical College, Kulasekharam.
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9442382082 |
| Fax |
|
| Email |
gynaehomoeopath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girija L |
| Designation |
Associate Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Sarada Krishna Homoeopathic Medical College Kulasekharam Kanniyakumari district Tamilndu India
Kulasekharam Kanniyakumari district Tamilndu India
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9442382082 |
| Fax |
|
| Email |
gynaehomoeopath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Girija L |
| Designation |
Associate Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Sarada Krishna Homoeopathic Medical College, College Building, 3rd Floor, Room No. 402, Department of Obstetrics and Gynaecology, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumaari District.
Sarada Krishna Homoeopathic Medical College, College Building, 3rd Floor, Room No. 402, Department of Obstetrics and Gynaecology, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumaari District.
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9442382082 |
| Fax |
|
| Email |
gynaehomoeopath@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ministry of AYUSH |
| Address |
AYUSH Bhawan B Block G P O Complex INA New Delhi 110023 |
| 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 L Girija Associate Professor |
Sarada Krishna Homoeopathic Medical College |
Clinical OPD IPD and RHCs Sarada Krishna Homoeopathic Medical College
Kulsekharam
Kanniyakumari
TAMIL NADU |
9442382082
gynaehomoeopath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Sarada Krishna Homoeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N87||Dysplasia of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Interventions-Acid Nitricum, Mercurius solubilus, Calendula Officinalis (Drugs selected according to individuals susceptibility and similimum according to Homoeopathic principles).
|
Interventions-Acid Nitricum, Mercurius solubilus, Calendula Officinalis (Drugs selected according to individuals susceptibility and similimum according to Homoeopathic principles).
Potency- in 200 C.
One Dose- Number 30 sized, 2 medicated globules dispensed in a grain of sugar of milk.
Frequency of repetition of dose -3 dose per week.
Route of administration will be oral.
Total duration of such intervention will be for 12 months.
Medicines Prescribed individually for each participant based on detailed case taking, symptom totality and miasmatic analysis.
Prescribed according to classical Hahnemannian principles.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Sexualy active women between the age group of 21years to 65 years Patients with cervical intra-epithelial lesion on LBC.
Participants willing to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Invasive cancer.
HIV positive or immunocompromised.
Pregnant/lactating women.
Sexually unexposed woman
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To explore the effect of individualized Homoeopathic medicines on
premalignant lesions of the cervix. |
Baseline: At recruitment (before initiation of treatment).
Follow-up 1: At 6 months post-initiation of treatment.
Follow-up 2: At 12 months post-initiation of treatment.
Final evaluation: At 18 months or end of post intervention follow-up period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To explore specific action of drugs on CIN at different stages.
|
Baseline: At recruitment (before initiation of treatment).
Follow-up 1: At 6 months post-initiation of treatment.
Follow-up 2: At 12 months post-initiation of treatment.
Final evaluation: At 18 months or end of post intervention follow-up period. |
| 2.To explore regression of lesion grade, and HPV status. |
Baseline: At recruitment (before initiation of treatment).
Follow-up 1: At 6 months post-initiation of treatment.
Follow-up 2: At 12 months post-initiation of treatment.
Final evaluation: At 18 months or end of post intervention follow-up period. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/12/2025 |
| 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="3"
Months="0"
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 - YES
- What data in particular will be shared?
Response (Others) - De-identified individual participant data from this study will be available on reasonable request to researchers for academic purposes after publication of the main study results. Data sharing will comply with institutional ethical guidelines and participants’ confidentiality will be fully maintained.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gynaehomoeopath@gmail.com].
- For how long will this data be available start date provided 01-05-2029 and end date provided 24-05-2033?
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
|
This single-arm interventional study aims
to evaluate the effectiveness of individualized Homoeopathic medicines in the
regression of cervical premalignant lesions among women in Kanniyakumari
district.
The primary objective is to assess whether
Homoeopathic medicines have a significant effect on premalignant cervical
lesions. Secondary objectives include exploring the specific action of certain
Homoeopathic drugs at different stages of cervical intraepithelial neoplasia
(CIN) and evaluating the regression of lesion grade and human papillomavirus
(HPV) clearance following individualized treatment.
Sexually exposed women aged 21 to 65 years
with CIN confirmed by VIA, VILI, colposcopy, liquid-based cytology, and HPV PCR
will be enrolled. Women exclusively under Homoeopathic treatment for all
complaints will be included. Exclusion criteria include sexually unexposed
women, pregnant or puerperal women, those with known HIV infection, or invasive
malignancies. Confirmed CIN 2 and CIN 3 cases will undergo detailed
Homoeopathic case-taking followed by individualized prescription.
Follow-up assessments will include VIA and
VILI every three months and LBC and HPV PCR every six months for twelve months
of intervention, with an additional six-month follow-up period. Pre- and
post-intervention outcomes will be compared using appropriate statistical
methods. A minimum of 100 participants will be enrolled, aiming for 125 to
account for attrition.
The study is expected to generate evidence
on the Homoeopathic management of cervical premalignant lesions and elucidate
stage-specific drug effects on CIN and HPV status. |