Efficacy and Safety of Fuke Qianjin Capsule in Patients With Pelvic Inflammatory Diseases
Pelvic Inflammatory Disease
About this trial
This is an interventional treatment trial for Pelvic Inflammatory Disease focused on measuring Triditional Chinese Medicine, Pelvic Inflammatory Disease (PID), Doxycycline Hyclate, Metronidazole
Eligibility Criteria
Inclusion Criteria:
- Female patients aged 18-55.
- History of sexual life.
- Consistent with the diagnosis of pelvic inflammatory disease.
- VAS score ≥4.
- Voluntarily participate in the clinical trial and signed the Informed Consent form obtained before any trial-related procedures are performed
Exclusion Criteria:
- Patients with severe pelvic inflammatory disease, or patients with dizziness, vomiting, high fever; pelvic abscess; fallopian tube ovarian abscess, etc; or patients with axillary temperature exceeding 38.5 ° C.
- Absence of uterus.
- Patients with gynaecological tumors (uterine fibroids > 3 cm in diameter, submucosal fibroids), specific vaginitis (trichomonal vaginitis, mycotic vaginitis, bacterial vaginosis), adenomyosis, endometriosis, pelvic venous stasis, tuberculous pelvic inflammatory disease, abnormal uterine bleeding, etc. confirmed by examination, and related symptoms caused by other diseases.
- Complicated with severe primary diseases of heart, liver, kidney, hematopoietic system and other vital organs and systems, which are judged by the investigator to have an impact on clinical trials. Liver function ALT or AST greater than the upper limit of normal 50%, renal function BUN or Cr greater than the upper limit of normal 20%.
- Combined with neurological and psychiatric disorders and unable or unwilling to cooperate.
- Allergic constitution (allergic to more than two substances) or allergic to the components of this drug; suspected or definite history of allergy to tetracyclines.
- Pregnant, breastfeeding, preparing for pregnant (within 6 months).
- Treated with similar drugs in the past 2 weeks.
- Those who are participating in or have participated in other clinical trials in the past 3 months.
- Suspected or confirmed history of alcohol or drug abuse, or other lesions or conditions that may reduce the possibility or complicate enrolment according to the judgment of the investigator, such as frequent changes in work environment and unstable living environment, which may easily lead to loss of follow-up.
Sites / Locations
- Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Fuke Qianjin capsule
Metronidazole tablets + Doxycycline hyclate tablets
Metronidazole tablets + Doxycycline Hyclate tablets simulant are consecutively taken for 14 days, while the Fuke Qianjin capsule is consecutively taken for 28 days. Fuke Qianjin Capsules are taken as 2 capsules at a time, 3 times a day, orally after breakfast, lunch, and dinner, respectively; Metronidazole Tablets are taken as 2 tablets (0.2 g/tablet) at a time, twice a day, at the same time as breakfast and dinner, respectively; Doxycycline Hyclate Tablet simulants are taken as 1 tablet (0.1 g/tablet, Doxycycline Hyclate Tablet calculated as C22H24N2O8) at a time, twice a day, at the same time as breakfast and dinner, respectively.
Metronidazole tablets + Doxycycline hyclate tablets are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days. Fuke Qianjin Capsules simulants are taken as 2 capsules at a time, 3 times a day, orally after breakfast, lunch and dinner, respectively; Metronidazole Tablets are taken as 2 tablets (0.2 g/tablet) at a time, twice a day, at the same time as breakfast and dinner, respectively; Doxycycline Hyclate Tablet simulants are taken as 1 tablet (0.1 g/tablet, Doxycycline Hyclate Tablet calculated as C22H24N2O8) at a time, twice a day, at the same time as breakfast and dinner, respectively.