Results of Clinical Study of Preparation “fertilogen”
(Manufacturer Sole Proprietor “Liana Rurua”)



Studying contingent: The study was conducted on 20 patients with acute and chronic non-specific inflammatory pathologies of reproductive systems. These patients were receiving out-patient treatment at Jsc Institute of skin and venereal diseases. 

The purpose
With the purpose of diagnose specification and establishment of criteria correspondence for participation in the study, in all patients were performed clinical-laboratory tests. Blood test for syphilis (RPR), smear bacterioscopy, smear immunoassay to detect trichomonas, ureaplasma, ultrasound of genitourinary tract, control study after discontinuation of treatment.
The preparation “Fertilogen” is antibacterial, anti-inflammatory drug.
Composition: Celandine herb 16.7 g, Rhizomes and Roots of Elecampane 2.5 g; Millefolii herba 41.7, Flores Helichryzi arenarii 8.3 g, Eucalyptus Leaves 8.3 g. 
20 patients (women) with acute and chronic non-specific inflammatory pathologies of reproductive system were chosen for the study, including 20-30 years of age – 6, 30-40 years of age – 8, above 40 years – 6. All of them were informed about the preparation “fertilogen”, instructions for use and they confirmed by signature their consent for the participation in the study. 
The preparation was administered to the patient in the form of tincture orally four times daily, three times 30-40 minutes before meal and fourth administration before bed-time, also locally once a day as vaginal wash. The treatment lasted 24 days.
Clinical control was performed on the 5th and 10th day after discontinuation of treatment. The results were evaluated by questionnaire, which contained the following information: intensity of discharge from the vagina (0- no, 1 – mild, 2 – moderate, 3 - severe); specific odor (0- no, 2 - yes); burning (0-no, 2 - yes); itching (0-no, 2- yes); paint in the pelvis; in the ovaries, back pain, associated with menstruation; fatigue; general condition. Evaluation of summarized effect was made according to 5 categories: full recovery, significant improvement, improvement, without effect, worsening.


Clinical study and results
The following complaints were manifested: discharge from the vagina – 18 patients including with specific odor - 3, itching and burning in the vagina – 10, pain in the pelvic region – 3, pain in the coccyx and back – 2, breast hardening – 1, oligomenorrhea -1, primary infertility – 1, secondary infertility - 1. Clinically: cervix hyperemia – 13, cervix hypertrophy – 4, erosion – 8, mucous-purulent discharge – 14, white discharge – 4.
Laboratory tests: In the vagina and cervix mass of leucocytes – 14.
Ultrasound: Inflammation of uterine adnexa – 1, uterine myoma - 2, salpingitis – 2, endometritis – 1, oophoritis with microcysts – 2, endocervical cysts – 2, bilateral fibroadenoma – 2, hydrosalpinx (blocked fallopian tube lumen) – 2 (chymopertubation). The majority of patients 17 (85%) on the first and the second controls (on 5th and 10th days of treatment) had the same complaints (in three patients developed new complaints: itching in the vagina, pain in the back and ovary region), by clinical observation decrease of inflammatory signs, including:

Vaginal discharge – 11 (55%) women,

Burning and itching in the vagina 6 (30%)

Pain in the back and ovary region – 3 (15%)

Cervical hyperemia – 12 (60%)

Cervical mucous hypertrophy – 3 (15%)

Erosion – 7 (35%)

Specific odor – 0 cases

3 (15%) patients on the first control didn’t have any subjective symptom and complete clinical remission was manifested.


One patient after 10 days of treatment developed increase of arterial pressure; she didn’t discontinue the treatment and the pressure stabilized by anti-hypertension drugs. In one patient on the 10th day of treatment was manifested two ovula-naboti of cervical gland, which ruptured during cervical examination.

After discontinuation of treatment the control showed the following results:
No subjective complaints.
Clniically: purulent vaginal discharge – 2, specific odor – 0, burning and itching in the vagina – 1, cervical hypertrophy – 1, cervical hyperemia – 3, erosion is epithelized in all cases.
Laboratory tests: a lot of leucocytes in the vagina and cervix – 3.
by ultrasound uterine myoma in both cases became smaller, after treatment in both patients fallopian tubes became free. Also no microcysts, cyst and endocervical cysts were manifested. 
No side effects were manifested in the patients (headache, vertigo, nausea, allergic reactions).

Thus, 24 day course of treatment with “Fertilogen” was effective in the treatment of acute and chronic non-specific inflammatory pathologies of the reproductive system, 17 (85%) – full recovery, in three cases improvement is manifested.
- “Fertilogen” is the effective drug for the treatment of acute and chronic non-specific inflammatory pathologies of the reproductive systems.
- The drug is well tolerated, doesn’t cause allergic reactions and is not characterized by other side effects.

Recommendations:

Fertilogen is recommended to use as tincture and locally, as the monotherapy, as well as in combination with other drugs. In case if after 24 day treatment course full recovery is not achieved, the treatment can be prolonged. In the future, we think to use this drug for the treatment of sexually transmitted infections, women infertility (primary and secondary), cysts of genital organs, cystic diseases and microcirculation pathologies of the pelvic organs.

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