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CTRI Number  CTRI/2024/12/078676 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 27/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Role Of Homoeopathy In Treatment Of Female Infertility 
Scientific Title of Study   Efficacy of Homoeopathy in Treating Cases of Female Infertility Using Kent 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  Amitkumar Naranbhai Gohel 
Designation  M.D. Scholar Part - 2 
Affiliation  C. D. Pachchigar College of Homoeopathic Medicine and Hospital 
Address  Department of Case taking and Repertory Division of MD 2nd floor C. D. Pachchigar College of Homoeopathic Medicine and Hospital Surat

Surat
GUJARAT
395001
India 
Phone  9825454231  
Fax    
Email  dr.amitgohel@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shirang N Vyas 
Designation  M. D. (Hom.) 
Affiliation  C. D. Pachchigar College of Homoeopathic Medicine and Hospital 
Address  Department of Case taking and Repertory Division of MD 2nd floor C. D. Pachchigar College of Homoeopathic Medicine and Hospital Surat

Surat
GUJARAT
395001
India 
Phone  9426185880  
Fax    
Email  drsnvyas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shirang N Vyas 
Designation  M. D. (Hom.) 
Affiliation  C. D. Pachchigar College of Homoeopathic Medicine and Hospital 
Address  Department of Case taking and Repertory Division of MD 2nd floor C. D. Pachchigar College of Homoeopathic Medicine and Hospital Surat


GUJARAT
395001
India 
Phone  9426185880  
Fax    
Email  drsnvyas@gmail.com  
 
Source of Monetary or Material Support  
CD Pachchigar College of Homoeopathic Medicine and Hospital Surat 395001 Gujarat India 
 
Primary Sponsor  
Name  CD Pachchigar College of Homoeopathic Medicine and Hospital 
Address  CD Pachchigar College of Homoeopathic Medicine and Hospital Near Anand Mangal Society Udhana Magadalla Road Bhatar Surat 395001 
Type of Sponsor  Private 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 Amitkumar Naranbhai Gohel  C. D. Pachchigar College of Homoeopathic Medicine and Hospital  Department of Case Taking and Repertory Division of MD 2nd Floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat India 395001
Surat
GUJARAT 
9825454231

dr.amitgohel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of CD Pachchigar College of Homoeopathic Medicine and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N979||Female infertility, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicine  Homoeopathic Medicine Doses As Per Requirement of Case Through Sublingual Mode of Administration within Time Duration of 9 Months 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Female patient Age group between 18 to 40 years.
Cases of PCOD, Endometriosis & Pelvic Inflammatory Diseases, Unexplained Infertility of Psychological (mental) causes.
Primary & Secondary Infertility 
 
ExclusionCriteria 
Details  Cases which having other causes like congenital defect of female genitalia.
Cases which having organic disease like tubal blockage.
Women whose husband’s semen analysis is abnormal. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Urine Pregnancy Test Positive   within 3 to 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
To Continuation of Pregnancy & Preventing Pregnancy loss with healthy life style  To Improve Health to Continuation of Pregnancy & Preventing Pregnancy loss with healthy life style within 9 months 
 
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   Phase 2 
Date of First Enrollment (India)   07/01/2025 
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="0"
Months="9"
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  
6.1 NEED FOR STUDY:
Female infertility is a significant health concern affecting a large number of women worldwide. It is defined as the inability of a couple to conceive even after one or more years of unprotected sexual intercourse (1).
The causes of female infertility are multifaceted and can include issues with the ovaries, uterus, fallopian tubes, and the endocrine system. 
Infertility can have profound psychological impacts, often leading to emotional stress, anxiety, depression, and low self-esteem. 
Since years long infertility in female is not merely a disease but a social stigma or curse for the suffering women. The painful cry of the suffering women from mental torture, criticism, humiliation, abuse (physical, mental, and verbal) and helplessness could only be heard by true physician, who is believed as an incarnation of almighty. Systems of medicines, whatever that may be the patients in this case need only a child, to be freed from the ‘curse’ of barrenness.
The purpose of repertory is to facilitate the search for the most similar remedy or remedies corresponding to a given set of symptoms. There are many repertories. To use them effectively, their structure, historical and evolutionary developments must be thoroughly studied before we can utilize them properly.
Utilizing Repertory like Kent’s Characteristic Repertory, in treatment of infertility in female, as infertility is multifactorial causative, there may be causes like physiological, pathological, and psychical disturbance which leading to couple, who cannot achieve their goal of conceiving (2). As Kent’s Characteristic Repertory helps to find some psychical (mental general causative factor); to find Physical and Pathological causative factor, for identifying causes and treating female infertility.

Thus, To Study “EFFICACY OF HOMOEOPATHY IN TREATING CASES OF FEMALE INFERTILITY USING KENT REPERTORY” is an effort in this direction to study causative and physiological, pathological, and psychical causes for female infertility.

6.2 REVIEW OF LITERATURE:

Homoeopathy is a system of medicine that treats the individual, considering the mental, emotional, physical, and constitutional aspects of the person. Homoeopathy aims to stimulate the natural healing power of the body and restore the balance of the vital force. Homoeopathic treatment is based on the principle of "like cures like.” (3)
Female infertility is defined as the inability of a couple to conceive even after one or more years of unprotected sexual intercourse. (1) Infertility can be primary, where the couple has never conceived, or secondary, where the couple has conceived at least once but is now unable to do so.
The causes of female infertility are multifaceted and can include issues with the ovaries, uterus, fallopian tubes, and the endocrine system. The most common cause is polycystic ovary syndrome (PCOS) (1), a hormonal disorder prevalent among reproductive-aged women. Other risk factors include smoking, obesity, alcohol consumption, advanced maternal age, sexually transmitted infections, and certain lifestyle factors.
Infertility can have profound psychological impacts, often leading to emotional stress, anxiety, depression, and low self-esteem. It can also strain relationships, sometimes resulting in divorce.
Female infertility can be diagnosed by a physical examination, medical history, and various tests to check the reproductive organs and hormones. Depending on the cause, female infertility can be treated with medications, surgery, or assisted reproductive technologies (ART) such as in vitro fertilization (IVF). The success rate of treatment depends on many factors, such as the age of the woman, the type and severity of the infertility, and the quality of the sperm. (2)
Homoeopathic treatment for female infertility is safe, natural, and effective, as it addresses the root cause of the problem and not just the symptoms. Homoeopathic treatment can help to regulate the hormonal levels, improve the ovarian function, enhance the quality of the eggs and the cervical mucus, reduce inflammation and infection, and increase the chances of conception. Homoeopathic treatment can also help to improve the mental and emotional state of the woman and her partner, by reducing stress, anxiety, depression, etc.
Kent repertory is one of the most widely used repertories in homoeopathy. It is a comprehensive and systematic collection of symptoms and their corresponding remedies, arranged in a logical order. Kent repertory is based on the philosophy of Kent, who emphasized the importance of generals over particulars, and mental symptoms over physical symptoms. Kent repertory has 37 chapters, covering various aspects of human health and disease.
Kent repertory can be used as a tool to find the most suitable homoeopathic remedy for female infertility cases. The homoeopathic physician can use Kent repertory to analyse the case history of the woman and her partner and elicit the characteristic symptoms that are peculiar to them.

• TYPOGRAPHY:
In Repertory of Homoeopathic Materia Medica with word index by Dr. J. T. Kent, here grading of symptoms as follow: (4)
ï‚  Bold                3
ï‚  Italics               2
ï‚  Roman             1
• REMEDIES: 648 remedies
• CHAPTERS: 37 Chapters

Study does not limit prescription up to therapeutics—it is based on individualization according to organon of medicine by Dr. Samuel Hahnemann, so utilizing whole of Kent’s repertory help to address female infertility from root cause.
According to Dr. Hahnemann, if the physician clearly perceives what is curative in medicine, that is to say, knowledge of medicinal powers; then the health must ensue, and the sick must be restored to healthy state. (3) So, this research will help us to identify the power to medicine to produce certain set of symptoms in the healthy state and by applying the law of similia, the indicated remedy can also cure it. Kent’s concept of Mental general (5) as cause & Physical general as effects gives clear indication of medicinal power and its sphere of action. Studying this will give great insight in treating the various female infertility cases with homoeopathy.


6.3 OBJECTIVE OF THE STUDY:
• To study Utility of Kent’s Repertory in treatment of Female infertility.
• To study “Efficacy of homoeopathic treatment of female infertility”


7 MATERIAL  AND  METHODS:
7.1 SOURCES OF DATA:

• PROJECT SITE – Cases will be taken from outpatient department and in-patient department of C. D. Pachchigar college of homoeopathic medicine, Surat.
• Peripheral OPD of C. D. Pachchigar college of homoeopathic medicine, Surat.
7.2 MATERIALS:
1. College O.P.D. Standard Case taking Performa.
2. Repertory of the Homoeopathic Materia Medica by J. T. Kent.
3. Computer software ; Zomeo.
4. Journals, websites, Organon of Medicine and Homoeopathic Philosophy books Materia Medica, Reference books, Repertories.
5. Patient information sheet.
Patient consent sheet.
7.3 METHOD OF COLLECTION OF DATA:
1. The study shall be performed in following ways:
2. Type of study: Clinical Experimental Study
3. Method of sampling: Purposive sampling
4. Collection of data from informed consent 
5. Examination of patient as per requirement of case
6. Diagnosis based on clinical history and as per required investigation.
7. Sample size: 30 
8. Duration of study: 09 months
Inclusion criteria:

1. Female patient Age group between 18 to 40 years.
2. Cases of PCOD, Endometriosis & Pelvic Inflammatory Diseases, Unexplained Infertility of Psychological (mental) causes.
3. Primary & Secondary Infertility

Exclusion criteria:

1. Cases which having other causes like congenital defect of female genitalia.
2. Cases which having organic disease like tubal blockage.
3. Women whose husband’s semen analysis is abnormal.

FOLLOW UP CRITERIA:

1. After 15 days, can vary according to requirement.

WITHDRAWAL CRITERIA:

1. Any complications which may arrive after the starting of treatment, Investigator may terminate the research on patient, regardless of his consent.
2. Patient not willing to continue the treatment can withdraw at any time with proper information to the investigator.

METHODS:

• Patients will be selected based on inclusion and exclusion criteria.
• Data collection instrument: standardized case records of College OPD.
• Settings: OPD of C. D. Pachchigar college of homoeopathic medicine, Surat & Peripheral OPD associated with college.
• Population: women visiting the Obstetrics & Gynecology OPD for infertility treatment.
• Patient were analyzed using investigation like Ultrasonography of abdomen & pelvis, Hysterosalpingography and Diagnostic Laparoscopy as and when required before and after treatment.
• Case taking will be done as per the instructions given by Dr. Hahnemann in aphorisms 83 – 104 in Organon of Medicine (6th edition).
• After proper analysis and evaluation of symptoms of the case, Totality of symptoms will be formed. 
• Similimum remedy will be selected from Utilizing Repertory of the Homoeopathic Materia Medica by Dr. J. T. Kent.
• Repertory of the Homoeopathic Materia Medica by Dr. J. T. Kent. as per totality of symptoms by using manual or computer reperterization.
• Potency and Dose – The remedies will be used in different potencies and repetition as per the requirement.
• Remedy will be administered in various potencies depending on the case. All the medicines will be administered through oral, sublingual route.
• Record – patient’s history, report and follow up will be kept in record.
• Data Analysis. 

RESPONSE WILL BE ANALYSED IN FOLLOWING WAY:

• Significant Improvement – when UPT test were positive for pregnancy & Antenatal USG confirmed live intrauterine gestational sac.
• Status quo – when there no conception or UPT test were negative.

7.4 DOES  THE  STUDY  REQUIRING ANY  INVESTIGATION  TO  BE CONDUCTED  ON  PATIENTS  OR OTHER  HUMANS  OR  ANIMALS? YES


7.5 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTE? YES

8. BIBLIOGRAPHY:

1. DUTTA DC. D C DUTTA’S TEXTBOOK OF GYNECOLOGY. In KONAR HK, editor..: Jaypee Brothers Medical Publishers (P) Ltd; NOVEMBER 2013.
2. invitra.com. [Online]. Available from: www.invitra.com.

3. Hahnemann S. Organon of Medicine. 6th ed.: Indian Books & Periodicals Publishers.
4. Tiwari SK. Essential of Reperterization. 6th ed. New Delhi: B. Jain Publishers; 2022.
5. Kent JT. Repertory of the Homoeopathic Materia Medica New Delhi: B. Jain Publishers; 2022.
6. Khanaj VR. Reperire - Repertory simplified. 5th ed. New Delhi: Indian Books & Periodicals Publishers; OCT-2018.
 
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