FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 

 
Close