Vaginitis Clinical Trial
Official title:
A Multicenter Clinical Study on Liquid-based Morphological Detection of Fungi
Verified date | July 2021 |
Source | Affiliated Hospital of Nantong University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The purpose of this study is to compare the results of different detection methods for non-gestational fungal vaginitis (VVC), and to evaluate the significance of different fungal states in the results for diagnosis and treatment.
Status | Enrolling by invitation |
Enrollment | 1000 |
Est. completion date | April 1, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 14 Years to 70 Years |
Eligibility | Inclusion Criteria: - 1. Samples from outpatient or inpatient clinics to be tested for fungal vaginitis. - 2. A sample of one or more of the following characteristics. 2.1 Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased. 2.2 Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd. - 3. The samples are vaginal secretions from the female body. Each sample should be the amount on one swab. - 4. The sample is not in menstrual period. - 5. The sample subjects did not have vaginal irrigation, medication or sexual intercourse within 3 days. Exclusion Criteria: - 1. Cases with incomplete specimen collection; - 2. Mixed vaginitis cases; - 3. Abscission cases with incomplete follow-up. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Ustc | Hefei | Anhui |
China | Jiujiang Maternal and Child Health Hospital | Jiujiang | Jiangxi |
China | Jiangxi Maternal and Child Health Hospital | Nanchang | Jiangxi |
China | Affiliated Hospital of Nantong University | Nantong | Jiangsu |
China | Affiliated Nantong Hospital Of Shanghai University | Nantong | Jiangsu |
China | Nantong Maternal and Child Health Hospital | Nantong | Jiangsu |
China | The Second Affiliated Hospital of Nantong University | Nantong | Jiangsu |
China | Children's Hospital of Fudan University Qidong Branch | Qidong | Jiangsu |
China | Changning District Maternal and Child Health Care Hospital | Shanghai | Shanghai |
China | Zhongshan City People's Hospital | Zhongshan | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Affiliated Hospital of Nantong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparing the positive detection rate of 3/4 different detection methods in the first phase. | The positive coincidence rate (sensitivity), negative coincidence rate (specificity) and total coincidence rate (consistency) was compared, according to the P<0.05 was used to determine whether it was statistically significant. | From Aug. 1st to Dec. 31st, 2021 | |
Primary | Calculating the proportion of the number of fungi in three different states in the map results of three/four detection methods. | Counting The number and proportion of mycelia, spores and blastospores, especially the percentage of cases of single spore (+) in all cases of fungus (+). | From Aug. 1st, 2021 to Jan. 31st, 2022 | |
Primary | Counting the positive numbers of 4 or 6 liquid-based thin-layer fungal fluorescence morphological tests and fungal culture in the Stage 2_follow-up stage. | the positive coincidence rate (sensitivity), negative coincidence rate (specificity) of 4 or 6 liquid-based thin-layer fungal fluorescence morphological tests | From Mar. 1, 2022 to Dec. 31st, 2022 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02515656 -
Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
|
Phase 3 | |
Recruiting |
NCT01420510 -
Saginil in vs. Placebo for Gynecologic Oncology Patients Affected by Vaginitis
|
Phase 2/Phase 3 | |
Completed |
NCT04079218 -
Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial
|
Phase 4 | |
Recruiting |
NCT05557318 -
Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge
|
N/A | |
Completed |
NCT01436513 -
A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.
|
Phase 1 | |
Completed |
NCT03585049 -
Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device
|
||
Completed |
NCT04676503 -
Vaginal and Rectal Colonization of Lactobacillus Crispatus NTCVAG04 Following Oral Administration in Patients With History of Vaginitis/Vaginosis
|
N/A | |
Completed |
NCT02641717 -
Validity of Patient-Collected Wet Mounts
|
N/A | |
Recruiting |
NCT05587283 -
Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Women
|
Phase 1 | |
Not yet recruiting |
NCT06070454 -
Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
|
N/A | |
Completed |
NCT02365389 -
Once Daily In-situ Forming Versus Twice-daily Conventional Metronidazole Vaginal Gels for Treatment of Bacterial Vaginosis
|
Phase 2/Phase 3 | |
Completed |
NCT01050465 -
MedlinePlus Health Prescriptions: Developing a Pragmatic Approach for Clinic Use
|
N/A | |
Completed |
NCT05652959 -
Real-world Performance and Safety of Cerviron® in the Treatment of Vaginitis
|
||
Recruiting |
NCT02763696 -
Establishment of a Sensitive System for Analysis of Child-bearing Women Vaginal Microbiota
|
N/A | |
Recruiting |
NCT04574089 -
Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository
|
Phase 3 | |
Recruiting |
NCT04816903 -
Gyni™ Study With Leumit Health Services
|
N/A | |
Completed |
NCT05670535 -
Sjögren and Gynecologic Considerations
|
||
Not yet recruiting |
NCT06438575 -
Point of Care Diagnosis of Vaginal Infections
|
N/A | |
Completed |
NCT03151928 -
Diagnostic Accuracy By Providers Study
|
||
Completed |
NCT05396261 -
a Flexible Wound Dressing for the Management of Genital Skin Conditions
|
N/A |