Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis
NCT03898401 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2019-04-02
Summary
30 postmenopausal females with senile vaginitis will be enrolled with score of \<15 on the Gloria Bachman Vaginal Health Index (VHI) intramucosal injections of PRP will be adminstered and perform clinical evaluations at 0, 1, 3, and 6 months.
Conditions
- Senile Vaginitis
Interventions
- COMBINATION_PRODUCT
-
Platelet rich plasma
After isolation of the PRP, calcium chloride (0.5ml) was added to the 5 ml of PRP isolate to activate the thrombin cascade, thereby causing degranulation of platelets, releasing growth factors and cytokines, and starting the transformation of the PRP to platelet rich fibrin matrix (PRFM) Before the PRFM became too gelatinous for passing through a needle (less than 10 minutes), two injections will be given through a 27-gauge needle in the posterior vaginal wall and perform clinical evaluations at 0, 1, 3, and 6 months.
Sponsors & Collaborators
-
Netherlands: Ministry of Health, Welfare and Sports
collaborator OTHER_GOV -
Ain Shams University
lead OTHER
Principal Investigators
-
Rasha Medhat, Professor · Ain Shams University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-18
- Primary Completion
- 2019-09-30
- Completion
- 2019-10-30
Countries
- Egypt
Study Locations
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