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CTRI Number  CTRI/2024/12/077899 [Registered on: 10/12/2024] Trial Registered Prospectively
Last Modified On: 09/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic Management Of Premenstrual Dysphoric Disorder 
Scientific Title of Study   A Single Group Pre-Post Intrventional Study To Assess The Effectiveness Of Individualised Homoeopathic Medicine In The Treatment Of Premenstrual Dysphoric Disorder Using Kents Repertory 
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 Suparja Sinha 
Designation  Post Graduate Trainee 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Dr. Bholanath Chakraborty Sarani, Dumurjola, Howrah Department- Repertory Division- OPD OPD no- 9

Haora
WEST BENGAL
711104
India 
Phone  9007573947  
Fax    
Email  sinha.suparja@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Samit Dey 
Designation  Professior 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Dr. Bholanath Chakraborty Sarani(Drainage Canal Road), Dumurjola Department - Repertory Division - OPD Room no - 9

Haora
WEST BENGAL
711104
India 
Phone  9875371414  
Fax    
Email  dr.samit77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suparja Sinha 
Designation  Post Graduate Trainee 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Dr. Bholanath Chakraborty Sarani(Drainage Canal Road), Dumurjola Department - Repertory Division - OPD Room no - 9

Haora
WEST BENGAL
711104
India 
Phone  9007573947  
Fax    
Email  sinha.suparja@gmail.com  
 
Source of Monetary or Material Support  
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr. Bholanath Chakraborty Sarani(Drainage Canal Road), Dumurjola, Howrah, Country-India Pin-711104 
 
Primary Sponsor  
Name  Dr Suparja Sinha 
Address  Dr. Bholanath Chakraborty Sarani(Drainage Canal Road), Dumurjola, Howrah 711104 
Type of Sponsor  Government medical college 
 
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 Suparja Sinha  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital  Department - Repertory Division - OPD Room no - 9 Dr. Bholanath Chakraborty Sarani(Drainage Canal Road), Dumurjola, Howrah 711104
Haora
WEST BENGAL 
9007573947

sinha.suparja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F328||Other depressive episodes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised Homoeopathic Medicine  Dose - 2 to 4 Potency - Both Centesimal(30C,200C,1M) and Fifty Millesimal potency will be used.All medicine procured will be GMP certified. Route of administration - orally. Frequency- 1 month interval Duration - 6 months for each patient Total study duration- 18 months  
Comparator Agent  N/A  N/A 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Women of Reproductive age group between 15 years to 49 years.
2. An increase in severity or presence of symptoms of DSM- V at least one of the physical and one of the mental symptoms 1-10 days before onset of
menses, for at least 2 preceding menstrual cycle.
3. The symptoms are associated with clinically significant distress or interference with work, school, usual social activities, or relationships with others
4.Relief of the above symptoms within 3 days of onset of menstrual cycle and not come back within at least 12 days of that cycle.
5.Patient who can give written consent or assent as needed. 
 
ExclusionCriteria 
Details  1. A professional athlete
2. Receive other treatment for PMS.
3. Patient with any malignancy.
4. Patient on OCP.
5. History of major psychriatic disorder over the past 2 years.
6. History of drug abuse, alcohol, hookah during the last 2 years. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Symptoms assessment by using Premenstrual symptom screening tool  At base line, 4th week, 8th week, 12th week, 16th week, 20th week, 24th week. 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life assessment using EQ-5D-5L scale  At base line, 4th week, 8th week, 12th week, 16th week, 20th week, 24th week 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
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)   24/12/2024 
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   INTRODUCTION :

  In mid 19th century the word Dysphoria originates from the Greek word ‘Dusphoria’ which means ‘hard to bear.’ Severe unhappiness, especially a person’s feeling of being very uncomfortable in their body or of being in the wrong body. Premenstrual dysphoric disorder (PMDD), a severe mood illness that affects millions of women globally, is characterized by cognitive-affective and somatic symptoms in the week preceding menstruation. 
  According to ICD -11 Code GA34.41, in premenstrual dysphoric disorder a pattern of mood symptoms (depressed mood, irritability), somatic symptoms (lethargy, joint pain, overeating), or cognitive symptoms (concentration difficulties, forgetfulness) that develops several days before the onset of menses, improves a few days after the onset, and then diminishes or disappears about one week after the onset of menses has been observed during the majority of menstrual cycles in the past year.
  In 2012, the American Psychiatric Association DSM-5 Executive Committee received a review of the latest research on PMDD from a committee of international experts on the pathophysiology and treatment of PMDD. The committee recommended that PMDD be included as a full diagnostic category in the DSM-5.
  According to recent epidemiological studies PMDD prevalence values generally population between 2-8% worldwide.
  The definite contributing factors of PMDD is still not clear, but some documents and discoveries have helped to unfold few of the mysteries of this disease. Deferent level of evidences variety of contributing factors to get a pathway to explore the neumerous causes of the disease.
  It is unknown to experts why certain people develop PMDD. Symptoms may be brought on by declining estrogen and progesterone levels following ovulation and prior to menstruation.
  Another possible factor is serotonin, a brain neurotransmitter that controls mood, appetite, and sleep. Similar to hormone levels, serotonin fluctuates during the menstrual cycle. 
  Mitigating the physical and mental symptoms that adversely affect an individual’s quality of life during the luteal phase of their menstrual cycle is the main objective of treating premenstrual dysphoric disorder (PMDD). Strategies for treatment aim to promote general well-being, improve everyday functioning, and lessen the intensity and duration of PMDD symptoms.
 In Homoeopathy the innermost core of philosophy allows treating patient on the idea of individualization. Homoeopathy provides a holistic approach to the patient as it is solely based on the principles of similarity, simplicity, and minimalism. Homoeopathy acts both as a preventive moreover as a curative mode of treatment because it relies on the totality of prescribing symptoms regardless of the name of disease. 


 JUSTIFICATION OF THE STUDY :

 Premenstrual dysphoric disorder (PMDD) is the severe form of premenstrual syndrome (PMS). Most young women have some degree of premenstrual issues, particularly in the early years of their reproductive lives. According to epidemiologic surveys, up to 80% of women of reproductive age report having symptoms related to the premenstrual period of the menstrual cycle. According to World Health Organization In India, almost one-fourth (27.7%) of the female populace is between the 15-29 age bracket are more likely to experience depression, anxiety, low self-esteem, and decreased vitality. This age represents a turning point in life linked to a surge in social, mental, emotional, and physical growth. Despite of conventional treatment with Antidepressent called SSRIs (selective serotonin reuptake inhibitors) and Contraceptive pills they are having various side effects including anxiety, dizziness, insomnia, sedation, nausea and headache. Large population of female of reproductive age group are visiting Mahesh Bhattacharyya Homoeopathic Medical College, with many of them are suffering from PMDD. The incidence of PMDD is drastically increasing due to stress, anxiety, work load, socio economic status, sedentary lifestyle and irregular food habits. Kent repertory is being used because of its ample content of general rubrics along with medicines, its ingenuity easy accessibility and usefulness worldwide. Premenstrual Dysphoric Disorder is an example of a disorder that lacks a particular targeted therapy in conventional medicine. Homoeopathy has been a popular choice among the patients for the treatment of such illnesses. Unfortunately, there haven’t been substantial evidence of research published on Premenstrual Dysphoric Disorder , which justifies our quest to work on this topic,

 âž¢ A case report published in PubMed titled with “Semi-standardised homeopathic treatment of premenstrual syndrome with a limited number of medicines: feasibility study” on July 2010; showed With help of an expert panel, 11 homeopathic medicines were selected, as well as predictive symptoms and characteristics (keynotes) for each medicine for treatment of PMS. The medicines selected (in rank order) were Sep, Nat-m, Lach, Cimic, Lac-c, Puls, Calc, Lil-t, Mag-p, Mag-c, Phos. 33 patients completed 3 months follow-up. Premenstrual symptom scores dropped by 50% or more in 12 patients and by 30-50% in 6 patients; scores dropped by less than 30% or increased in 12 patients.

 âž¢ Effects of homeopathic treatment in women with premenstrual syndrome: a pilot study showed the efficacy of homeopathic treatment in relieving symptoms associated with premenstrual syndrome (PMS). Two months baseline assessment with post-intervention follow-up for 3 months was conducted at Hadassah Hospital outpatient gynaecology clinic in Jerusalem in Israel . The subjects were 20 women, aged 20-48, suffering from PMS. Homeopathic intervention was chosen individually for each patient, according 3 6.2 6.3 to a model of symptom clusters. The main outcome measure was scores of a daily menstrual distress questionnaire (MDQ) before and after treatment. Mean MDQ scores fell from 0.44 to 0.13 (P<0.05) with active treatment, and from 0.38 to 0.34 with placebo (NS).Improvement >30% was observed in 90% of patients receiving active treatment and 37.5% receiving placebo (P=0.048). Homeopathic treatment was found to be effective in alleviating the symptoms of PMS in comparison to placebo.

 âž¢ Another study published in ‘Thieme Homoeopathy’ e-journal titled with “A Placebo-Controlled Double-Blind Randomized Trial with Individualized Homeopathic Treatment Using a Symptom Cluster Approach in Women with Premenstrual Syndrome” in August 2019 showed that in an outpatient department of a university clinic in Jerusalem, Israel (1996–1999), women with PMS, aged 18 to 50 years, entered a 2-month screening phase with prospective daily recording of premenstrual symptoms by the Menstrual Distress Questionnaire (MDQ). A total of 105 women were included. 43 women in the active medicine group and 53 in the placebo group received the allocated intervention with at least one follow-up measurement and their data were analyzed. Significantly greater improvement of mean PM scores was measured in the active medicine group. Individually prescribed homeopathic medicines were associated with significantly greater improvement of PM scores in women with PMS, compared to placebo. 

A combined analysis of all of these research yields a good result demonstrating the potential of homoeopathic medications to cure PMDD; in addition, investigations have revealed that homoeopathy has played a significant role in improving patients’ quality of life. To further understand the extent and limitations of homoeopathic medications in the treatment of PMDD, more high-quality, unbiased observational studies are needed. Patients commonly attend to Mahesh Bhttacharyya Homoeopathic MedicalMCollege and Hospital’s OPD and IPD with a variety of gynaecological conditions, and utilising the available infrastructure it could be an ideal set up for this study.


 RESEARCH QUESTION:
 â€¢ Does individualized homoeopathic medicine is efficacious in treating premenstrual dysphoric disorder? 


 HYPOTHESIS: 
 NULL HYPOTHESIS (HO): • There is no role of individualized homoeopathic medicine in the treatment of premenstrual dysphoric disorder. 
 ALTERNATIVE HYPOTHESIS (HA): • Individualized homoeopathic medicine has significant role in the treatment of premenstrual dysphoric disorder. 
 
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