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Clinical Trials/CTRI/2022/11/047748
CTRI/2022/11/047748RecruitingPhase 2

A PROSPECTIVE STUDY TO ASSESS THE EFFECT OF HOMOEOPATHIC TREATMENT IN THE MANAGEMENT OF ENDOMETRIOSIS

PONNU C1 site in 1 country33 target enrollmentStarted: March 12, 2022Last updated:

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
33
Locations
1
Primary Endpoint
Changes in Endometriosis Health Profile questionnaire score before and after Homoeopathic treatment of Endometriosis

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •Patients with symptoms and signs of endometriosis •Female, 20-60 years old •Cases fulfilling the examination findings and transvaginal USG finding.

Exclusion Criteria

  • 1.Asymptomatic case of endometriosis 2.Complicated endometriosis cases requiring surgery 3.Cases with psychiatric illness 4.Any active malignancy.

Outcomes

Primary Outcomes

Changes in Endometriosis Health Profile questionnaire score before and after Homoeopathic treatment of Endometriosis

Time Frame: 1 YEAR

Changes in Marinoff dyspareunia scale before and after Homoeopathic treatment of Endometriosis

Time Frame: 1 YEAR

Changes in transvaginal USG findings before and after Homoeopathic treatment of Endometriosis

Time Frame: 1 YEAR

Secondary Outcomes

  • 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)

Investigators

Sponsor
PONNU C
Sponsor Class
Other [self]

Study Sites (1)

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