| CTRI Number |
CTRI/2024/06/069050 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to understand the management of primary dysmenorrhoea with the help of homoeopathic repertory |
|
Scientific Title of Study
|
Ascertaining the utility of Boger Boenninghausens characteristic repertory in the homoeopathic management of primary dyemenorrhoea |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAnjana S Mohan |
| Designation |
MD (HOM) scholar |
| Affiliation |
Dr MGR Medical University, ChennaiWhite Memorial Homeo Medical college and hospital |
| Address |
Department of Repertory
White Memorial Homoeopathic Medical College and Hospital
Atoor Veeyyanoor Kanniyakumari District
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9567347387 |
| Fax |
|
| Email |
dranjanasmohan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dominin Raj |
| Designation |
Head of the Department of Repertory |
| Affiliation |
white memorial homeo medical college and hospital |
| Address |
Department of Repertory
White Memorial Homoeopathic Medical College and Hospital
Atoor,Veeyanoor PO, Kanniyakumari,Tamil Nadu
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9447654467 |
| Fax |
|
| Email |
drdomininrajrk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjana S Mohan |
| Designation |
MD (HOM) scholar |
| Affiliation |
White Memorial Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory
White Memorial Homoeopathic Medical College and Hospital
Atoor Veeyyannoor Kanniyakumari District
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9567347387 |
| Fax |
|
| Email |
dranjanasmohan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Repertory, White Memorial Homoeo Medical College and Hospital,Attoor,Kanniyakumari,Tamil Nadu
Pin Code 629177 |
|
|
Primary Sponsor
|
| Name |
White Memorial Homoeopathic Medical College and Hospital |
| Address |
White Memorial Homoeopathic Medical College and Hospital, Atoor Veeyyannoor,Kanyakumari,Tamil Kanniyakumari District
Pin Code 629177 |
| 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 Anjana S Mohan |
White Memorial Homoeopathic Medical College |
Department of Repertory
White Memorial Homoeopathic Medical College and Hospital,Attoor,Veeyyannoor,Pin Code 629177
Kanniyakumari
TAMIL NADU |
9567347387
dranjanasmohan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| white memorial homoeo medical college and hospital ethics commitee WMHMCH-EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine selected using repertory |
WALIDD score used for pre and post evaluation.Homoeopathic medicine selected from Boger Boenninghausens charecteristic repertory based on symptom similarity will be administrated to the patients
Dose-minimum dose
Route of administration-oral
Each case will be assessed monthly and follow up will be done for 6 months.
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
only unmarried and nulliparous females
normal ultrasound scanning report of pelvis
patient fullfilling the case definition of primary dysmenorrhoea
patient with consent and co-operate for regular follow up |
|
| ExclusionCriteria |
| Details |
females below 13 years and above 25 years who are married and undergone labor
patients who require emergency medical intervention
patient with any other systemic diseases
patient taking other medications
patients not fulfilling definition of primary dysmenorrhoea |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Each case is assessed by using WALIDD score and Boger Boenninghausens Charecteristic Repertory. Each case reviewed at one month interval or as per their need in case of emergency |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| After completion of study & follow up, assesment of WALIDD score will be done & will ascertain the utility of Boger Boenninghausens Charecteristic repertory in management of primary dysmenorrhoea |
1 year |
|
|
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)
|
25/06/2024 |
| 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 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- 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 (Others) - All the data to be provided when needed through email - dranjanasmohan@gmail.com
- For how long will this data be available start date provided 18-03-2026 and end date provided 18-03-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
A minimum of 40 cases will be selected by purposive sampling from the outpatient , inpatient and peripheral centers of White Memorial Homoeopathic Medical college and hospital. Case taking and recording will be done in pre-structured case sheet of White Memorial Homoeopathic medical college and hospital. Ultra sonography will be done to confirm no pathology. Repertorial totality according to homoeopathic principles with the aid of Boger Boenninghausen’s characteristic repertory. Final prescription after refernce with materia medica and potency selection and follow up according to principles laid down in organon. Observation will be noted in tables and charts. The post intervention data will be analysed and conducted withion one year .Pre and post assessment analysis will be assesed by WALLID score. |