| 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
|
|
|
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
|
|
|
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 |