Efficacy of Dead Sea Peloid Gel in Chronic Endometritis

Chronic Endometritis Clinical Trial

Official title:

Efficacy of Intravaginal Dead Sea Peloid Gel Administration in Complex Treatment of Chronic Endometritis and Reproductive Disorders: Randomized Placebo-controlled Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680275
• Other study ID #: 16
• Status: Completed
• Phase: N/A
• First received: December 22, 2015
• Last updated: February 10, 2016
• Start date: July 2011
• Est. completion date: June 2013

Study information

• Verified date: September 2015
• Source: Scientific Center for Family Health and Human Reproduction Problems, Russia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: FSI Scientific Center of Expertise of Medical Application
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of Dead Sea Peloid Gel in the treatment of Chronic Endometritis in women with reproductive disorders. Half of participants will receive Dead Sea Peloid Gel and antibiotics, while the other half will receive Placebo Gel and antibiotics.

Patients with reproductive disorders who visited Research Medical Center of Family Health Problems and Human Reproduction were recruited.

Description:

Dead Sea Peloid Gel achieves improvement of blood circulation and receptor sensitivity of endometrium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women with miscarriage associated with chronic endometritis

• Women without mental disorders able to swallow tablets

Exclusion Criteria: Clinical diagnosis of:

• sexually transmitted diseases

• endometrium hyperplasia and/or polyps

• uterina fibroids

• endocrine disorders

• trombophilia

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Endometritis
• Endometritis

Intervention

Drug:
• Dead Sea Peloid Gel
intravaginally

Locations

Country	Name	City	State
Russian Federation	Scientific Center for Family Health and Human Reproduction Problems	Irkutsk

Sponsors (1)

Lead Sponsor	Collaborator
Scientific Center for Family Health and Human Reproduction Problems, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of spontaneous pregnancy the first year after treatment		during first year	No
Secondary	The prevalence of women with morphological status of chronic endometritis by the 3 months after treatment.		during 3 months	No