| CTRI Number |
CTRI/2024/11/077150 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| 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 on Primary Dysmenorrhoea |
|
Scientific Title of Study
|
Effect of Individualized Homoeopathic Medicine on Pain Intensity and Quality of Life in Patients with Primary Dysmenorrhoea Using Kent’s Repertory: A Single Group Pre-Post Interventional Study |
| 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 Santana Maity |
| Designation |
Post graduate trainee |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Dr.B.N.Chakraborty Sarani,Doomurjala,Howrah-711104,Department of Repertory
Haora WEST BENGAL 711104 India |
| Phone |
9434985407 |
| Fax |
|
| Email |
santanamaity31@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Purnendu Ash |
| Designation |
Reader |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Dr.B.N.Chakraborty Sarani,Doomurjala,Howrah-711104, Department of Repertory
Haora WEST BENGAL 711104 India |
| Phone |
9051420436 |
| Fax |
|
| Email |
purnendubhms29@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Purnendu Ash |
| Designation |
Reader |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Dr.B.N.Chakraborty Sarani,Doomurjala,Howrah-711104,Department of Repertory
Haora WEST BENGAL 711104 India |
| Phone |
9051420436 |
| Fax |
|
| Email |
purnendubhms29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College and Hospital.Dr. B.N.Chakraborty Sarani,Doomurjala,Howrah-711104,West Bengal,India |
|
|
Primary Sponsor
|
| Name |
Dr Santana Maity |
| Address |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Doomurjala, Howrah,Department of Repertory |
| 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 Santana Maity |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Dr.B.N.Chakraborty sarani,Doomurjala,Howrah-711104, OPD no- 5 Haora WEST BENGAL |
9434985407
santanamaity31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,MAHESH BHATTACHARYYA 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 of indicated homoeopathic medicine in centesimal potency on the basis of individualization. Each dose will consist of 4 cane sugar globules of no. 40 moistened with the indicated medicine,to be taken orally on clean tongue with empty stomach. Dose and frequency of repitition will depend upon the individual requirement of the cases. All the medicines procured will be Good Manufacturing Practices(GMP) certified. Follow up will be done on a regular basis, every month upto 3 months. Total duration of intervention will be 3 months. Route of administration : Oral. Along with medicines, dietary advice will be given as per patients requirement. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Female aged between 12 to 30 years presenting with typical history of Primary Dysmenorrhoea
Female patients who are suffering from atleast 6 months with spasmodic pain of sufficient magnitude during menses lasting not more than 72 hours, without any diagnosed ovarian or uterine pathology.
Patients willing to give written consent/assent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Diagnosed or suspected cases of secondary dysmenorrhea due to any abnormal pelvic pathology in Ultrasonography of lower abdomen.
Patients having unevaluated gynaecological abnormalities; e.g. unexplained vaginal bleeding, cervical dysplasia, pelvic inflammatory diseases within one month.
Patients using oral contraceptive pills, hormone replacement therapy or corticosteroids or having a history of their use in previous 3 months
Diagnosed cases of uncontrolled systemic diseases, unstable psychiatric illness or other life-threatening illnesses or any vital organ failure.
Undergoing any homoeopathic treatment for a chronic condition(s) within last 1 month.
Substance abuse and/or dependence
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WaLIDD score for assessing severity of pain during Primary Dysmenorrhoea |
Each patient will get follow-up for at least 3 months at the interval of 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EQ-5D-5L questionnaire for assessing the impact on quality of life |
Each patient will get follow-up for at least 3 months at the interval of 1 month |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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)
|
20/11/2024 |
| 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) |
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
|
Dysmenorrhoea is a Greek term and literally means "painful monthly bleeding" where the words ‘dys’ meaning difficult, painful or abnormal, ‘meno’ meaning month and ‘rrhoea’ meaning flow. But a more realistic and practical definition of Dysmenorrhoea (ICD-11 code:GA34.3) includes cases of painful menstruation of sufficient magnitude so as to incapacitate day to day activities.Dysmenorrhea is considered as one of the most common gynaecological disorders among females of childbearing age. Although it is a common condition, it is usually underdiagnosed, since most females do not seek medical attention.Dysmenorrhoea is of two types: primary and secondary. Primary Dysmenorrhoea (PD) refers to presence of painful menses where there is no underlying pathology that can account for pain. On the other hand, Secondary Dysmenorrhoea (SD) is defined as menstrual pain occurring in the presence of pelvic pathology.The worldwide prevalence of Primary Dysmenorrhoea ranges from 45% to 95% females of reproductive age and a greater prevalence (70% to 90%) was noted among young females of age less than 24 years and in India the prevalence is 70.2%. Primary dysmenorrhoea usually appears 6-12 months after menarche because it occurs only during ovulatory cycles and begins to decline beyond 30 years of age with peak prevalence between 18-24 years of age.The clinical manifestations of Primary Dysmenorrhoea have tremendous negative effect on quality of life among young females. A study in India shows approximately 50% of dysmenorrheic girls remained absent from school or colleges. The goal of the treatment of Primary Dysmenorrhoea is to provide adequate relief from menstrual pain and improvement in quality of life of young females. Despite of relief from pain by the standard pharmacological treatment by Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Oral contraceptive Pills (OCPs), patients suffering from Primary Dysmenorrhoea still report perplexing residual symptoms like indigestion, headaches, drowsiness, irregular bleeding drastically affecting their Quality of life (QoL). Several studies reported these symptoms as the adverse effects of NSAID and OCP if used for a long period of time. Therefore, many women often opt for homoeopathic treatment to cope with the condition and chiefly avoid conventional treatment for side effects. Homoeopathy is a holistic system of medicine and acts generously on psychosomatic spheres for the case of Primary Dysmenorrhoea. There are very few studies conducted in India as well as worldwide, to determine effectiveness of homoeopathic medicines in the treatment of Primary Dysmenorrhea and related quality of life, which had shown both positive and negative results. In dearth of evidence, the rationale of this study is aimed to evaluate the effect of individualized homoeopathic medicines on pain intensity and quality of life of patients suffering from Primary Dysmenorrhoea using Kent’s repertory which is being used for its ample content of general rubrics along with medicines, easy accessibility and extensive use throughout the world.
Research Question: Is individualized homoeopathic medicine effective on reducing pain intensity and improving quality of life in patients suffering from Primary Dysmenorrhoea? Hypothesis: Null Hypothesis(H0): There is no significant role of individualized homoeopathic medicine in the reduction of pain intensity and improvement of quality of life in the patients of Primary Dysmenorrhoe Alternative Hypothesis (HA): Individualized homoeopathic medicines have a significant role in reduction of pain intensity and improvement of quality of life in the patients of Primary Dysmenorrhoea |