| CTRI Number |
CTRI/2024/05/067930 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic medicine in primary dysmenorrhea |
|
Scientific Title of Study
|
Utility Of O.E.Boerickes Repertory In Management Of Cases Of Primary Dysmenorrhea |
| 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 Shailej |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital,Lucknow |
| Address |
Department of Case Taking and Repertory,State National Homoeopathic Medical College and Hospital,1-Viraj Khand,Gomti Nagar,Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8881317128 |
| Fax |
|
| Email |
sonalchaudhary2212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sutapa Nandi |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College and Hospital,Lucknow |
| Address |
Department of Case Taking and Repertory,State National Homoeopathic Medical College and Hospital,1-Viraj Khand,Gomti Nagar,Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
6351407744 |
| Fax |
|
| Email |
drnandisutapa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailej |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital, Lucknow |
| Address |
Department of Case Taking and Repertory,State National Homoeopathic Medical College and Hospital,1-Viraj Khand,Gomti Nagar,Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8881317128 |
| Fax |
|
| Email |
sonalchaudhary2212@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and Hospital, 1-Viraj Khand, Gomti Nagar, Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr. Shailej |
| Address |
Department of Case Taking and Repertory, State National Homoeopathic Medical College and Hospital,1-Viraj Khand,Gomti Nagar,Lucknow, Uttar Pradesh-226010 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shailej |
State National Homoeopathic Medical College and Hospital |
State National Homoeopathic Medical College and Hospital, 1-Viraj Khand, Gomti Nagar, Lucknow, Uttar Pradesh-226010
Lucknow
UTTAR PRADESH |
8881317128
sonalchaudhary2212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee of State National Homoeopathic Medical College and Hospital |
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 |
Individualized homoeopathic medicine |
Intervention is planned as administering via oral route indicated homoeopathic medicine in patients suffering from primary dysmenorrhea after detailed case taking and repertorization. Individualized homoeopathic medicine will be given in varying potencies of centesimal scale depending upon the susceptibility of the patient. Each dose shall consist of 4-5 globules of cane sugar medicated with single medicine (preserved in 90%v/v ethanol) to be taken orally on an empty stomach. Dosage and repetition will depend upon the individual requirement of the cases. The patient will be called for follow up after every 15 days and the final assessment will be done after 6 months. At every follow up after reexamining the case it will be decided whether the patient will receive a dose of individualized homoeopathic medicine or placebo. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient of age between 13 years to 25 years of female. 2.Females suffering from Primary dysmenorrhoea.3. Females with painful menstruation within past 3 months.
4.Patient of all socioeconomic with all religions. 5.Normal menstrual cycle for more than 6 months. |
|
| ExclusionCriteria |
| Details |
1.Are taking any form of hormonal contraceptives and IUCD.
2.Prediagnosed polycystic ovarian syndrome other causes of secondary
dysmenorrhoea or any other systemic disease.
3.Patient who suffering from life threatening disease.
4.Patient who taking life saving drugs.
5.Being under the age of 13 and above the age of 26. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the score of Numerical Pain Rating Scale at baseline and after 6 months of treatment to know the utility of individualized homoeopathic medicine. |
12 weeks, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the score of Numerical Pain Rating Scale at baseline and after 3 months to assess the utility of Boericke Repertory in selection of individualized homoeopathic medicine. |
4 weeks,12 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
07/06/2024 |
| 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="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 - NO
|
|
Brief Summary
|
This is an open label ,single arm,prospective, interventional study which aims to assess the utility of individualized homoeopathic medicine in the treatment of Primary Dysmenorrhea.Individualized homoeopathic medicine will be prescribed in centesimal scale after detailed case taking and repertorization with the help of Boericke repertory. Numerical Pain Rating Scale will be calculated every month upto 6 months. The difference between the Numerical Pain The worldwide prevalence of PD ranges from 45% to 95% in females of reproductive age, with 2% to 29% experiencing severe pain. This variation in the rates may be explained by the differences between the methodologies used to assess PD, the selected population, age groups, ethnicity, and pain perception differences among communities. A greater prevalence (70% to 90%) was generally reported among younger women (<24 years). Rating Scale before and after the treatment will be compared and analyzed.A more holistic approach is required for the treatment of Primary dysmenorrhoea cases by considering their mental, physical, spiritual and economical aspects. This approach is not new for Homoeopathic mode of treatment because in Homoeopathy we always treat the patient with a holistic approach by considering the individuality of the patient.
Therefore, the present study is undertaken to explore how individualized homoeopathic medicine selected on the basis of Boericke Repertory can prove to be useful in the treatment of Primary Dysmenorrhoea. |