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CTRI Number  CTRI/2022/11/047748 [Registered on: 28/11/2022] Trial Registered Prospectively
Last Modified On: 05/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   HOMOEOPATHIC TREATMENT IN ENDOMETRIOSIS 
Scientific Title of Study   A PROSPECTIVE STUDY TO ASSESS THE EFFECT OF HOMOEOPATHIC TREATMENT IN THE MANAGEMENT OF ENDOMETRIOSIS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PONNU C 
Designation  JUNIOR RESIDENT 
Affiliation  GOVT HOMOEOPATHIC MEDICAL COLLEGE 
Address  DEPARTMENT OF PRACTICE OF MEDICINE GOVT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL KARAPARAMBA

Kozhikode
KERALA
673010
India 
Phone  9947688102  
Fax    
Email  dr.ponnusivadasan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR P ABDUL HAMEED 
Designation  PROFESSOR AND HOD,  
Affiliation  GOVT HOMOEOPATHIC MEDICAL COLLEGE 
Address  DEPARTMENT OF PRACTICE OF MEDICINE GOVT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL KARAPARAMBA

Kozhikode
KERALA
673010
India 
Phone  9447632227  
Fax    
Email  hameeddr@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DR P ABDUL HAMEED 
Designation  PROFESSOR AND HOD,  
Affiliation  GOVT HOMOEOPATHIC MEDICAL COLLEGE 
Address  DEPARTMENT OF PRACTICE OF MEDICINE GOVT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL KARAPARAMBA

Kozhikode
KERALA
673010
India 
Phone  9447632227  
Fax    
Email  hameeddr@yahoo.com  
 
Source of Monetary or Material Support  
GOVT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL KOZHIKODE 
 
Primary Sponsor  
Name  PONNU C 
Address  GOVT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL KARAPARAMBA KOZHIKODE KERALA 673010 
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 PONNU C  GOVT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL  INFERTILITY OP THIRD FLOOR NEW BLOCK GOVT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL KARAPARAMBA
Kozhikode
KERALA 
09947688102

dr.ponnusivadasan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE GOVT HOMOEOPATHIC MEDICAL COLLEGE KOZHIKODE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N80||Endometriosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HOMOEOPATHIC MEDICINES  SUITABLE HOMOEOPATHIC MEDICINE WILL BE SELECTED BASED ON THE SYMPTOM TOTALITY DOSE AND POTENCY WILL BE SELECTED ON THE BASIS OF HOMOEOPATHIC PRINCIPLES ROUTE OF ADMINISTRATION WILL BE ORAL AND TOTAL DURATION OF TREATMENT WILL BE 1 YEAR 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  •Patients with symptoms and signs of endometriosis
•Female, 20-60 years old
•Cases fulfilling the examination findings and transvaginal USG finding
 
 
ExclusionCriteria 
Details  1.Asymptomatic case of endometriosis
2.Complicated endometriosis cases requiring surgery
3.Cases with psychiatric illness
4.Any active malignancy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in Marinoff dyspareunia scale before and after Homoeopathic treatment of Endometriosis
Changes in Endometriosis Health Profile questionnaire score before and after Homoeopathic treatment of Endometriosis
Changes in transvaginal USG findings before and after Homoeopathic treatment of Endometriosis
 
1 YEAR 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Marinoff dyspareunia scale before and after Homoeopathic treatment of Endometriosis
Changes in Endometriosis Health Profile questionnaire score before and after Homoeopathic treatment of Endometriosis
Changes in transvaginal USG findings before and after Homoeopathic treatment of Endometriosis  
6 MONTHS 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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)   03/12/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Presence of functioning endometrium in sites other than uterine mucosa is called endometriosis. These islands of endometriosis are composed of endometrial glands surrounded by endometrial stroma, and are capable of responding to a varying degree to cyclical hormonal stimulation. Endometriosis is a disease of contrast. It is a benign but it is locally invasive, disseminates widely. Cyclic hormones stimulate growth but continuous hormone suppress it.

The occurrences of endometriosis are genetic, multifactorial, vaginal or cervical atresia encouraging retrograde spill. The more frequent the cycles and more the bleeding, greater is  the risk of endometriosis. Risk factors are polymenorrhagia, retroverted uterus, which increases the risk of retrograde spill.

The common site of endometriosis are ovaries, the pouch of Douglas, including the utereosacral ligaments, peritoneum overlying the bladder, sigmoid colon, back of uterus, ovarian fossa, intestinal coils and appendix. Endometriosis is seen in the umbilicus following an operation, in laparotomy scar, in tubal stumps following sterilization operation, in amputated stumps of the cervix and in the scars  of the vulva and perineum.

Symptoms include  Dysmenorrhoea, Adominal pain, Dyspareunia, Infertility, Menstrual symptoms, Chronic pelvic pain, Urological and bowel symptoms.

RATIONALE OF STUDY

Endometriosis is a common gynaecological condition affecting 2-10% of women of childbearing age. At present, there is no known way to prevent endometriosis. Enhanced awareness, followed by early diagnosis and management may slow or halt the natural progression of the disease and reduce the long-term burden of its symptoms, including possibly the risk of central nervous system pain sensitisation, but currently there is no cure.

Usual allopathic treatment include hormone therapy and minimal invasive surgery. Hormone therapy suppresses endometriosis for the duration of therapy, it does not prevent recurrence. Moreover, hormone delay pregnancy by their contraceptive effect, beside the drugs being expensive. Weight gain, irregular bleeding, reduced libido, mental depression are other side effect

Homoeopathy being a holistic system of medicine has a better scope in the management of endometriosis; a constitutional approach can be adopted in homeopathy. Previous studies on the role of homeopathy in treating endometriosis are also limited. Homoeopathy is cost effective; prevent recurrence and has no side effects. Thus, this study focuses on the usefulness of homeopathic medicines in the management of endometriosis 
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