Report on conducting a clinical trial

1. The aim and task of the research

The purpose of this study was to evaluate the effectiveness and tolerability of the drug API‑NORM<sup>®</sup> in the treatment of ectopy of the cylindrical epithelium (ECE) against the background of nonspecific vaginitis.

Tasks of the research:

  1. study of the effect of the researched drug on the course of the disease.
  2. study of tolerability and possible side effects of the studied drug.

2. Introduction and rationale

Along with traditional methods of treatment, recently, old and new non-traditional methods, which include the use of natural preparations based on api-phyto components, are gaining more and more popularity among doctors. A representative of this group is API-NORM suppositories, which include propolis extract, beeswax, St. John's wort extract, calendula oil, sea buckthorn oil. The drug exhibits anti-inflammatory, antiviral, antispasmodic, reparative effects.

3. Research design

The study included 28 women of reproductive age who were diagnosed with ECE against the background of non-specific vulvovaginitis. ECE was established colposcopically. Non-specific colpitis - based on complaints, clinical picture and confirmed by bacterioscopy of urogenital secretions.

During the gynecological examination the localization and prevalence of inflammation, the presence of swelling, hyperemia on the mucous membrane, the amount, smell and nature of secretions were taken into account.

Evaluation of subjective complaints was carried out according to the following criteria:

  • itching, burning in the vagina;
  • discomfort during sexual life;
  • presence of discharge from the vagina.

During bacterioscopy the following were taken into account:

  • type and number of microorganisms;
  • number of leukocytes.

Colposcopy data:

  • normal colposcopic picture;
  • inflammatory process;
  • ectopy of the cylindrical epithelium;
  • leukoplakia;
  • dysplasia of the cervix.

All patients included in the study were prescribed API-NORM one suppository vaginally once in the evening for 10 days. Examinations were carried out before treatment and 2 weeks after its end.

4. Assessment of efficacy and tolerability

4.1 Performance criteria:

  • dynamics of decreasing severity of clinical manifestations of the disease (itching, heartburn, discharge);
  • positive dynamics according to bacterioscopic examination of vaginal swabs;
  • positive dynamics according to the data of colposcopy (reduction of the phenomena of the inflammatory process, reduction of ECE).

4.2 Evaluation of the tolerability of the studied drug

Tolerability of the drug was assessed on the basis of subjective symptoms and sensations reported by the patient and objective data obtained by the researcher during treatment. The dynamics of laboratory indicators, as well as the frequency of occurrence and nature of adverse reactions were taken into account.

Tolerability of the drug was assessed by the researcher in points according to the following scale:

  1. unsatisfactory
  2. satisfactory
  3. good

5. Clinical trial data processing and report

All women before the start of treatment complained about the presence of abundant secretions from the genital tract, which met the criteria for inclusion in the study. In most patients, the onset of the disease was accompanied by the appearance of itching, heartburn in the genital area of varying degrees of severity, discomfort during sexual life (Table 1). The complaints listed above were evaluated as 1 point - for a light degree of their severity, 2 - for medium and 3 - for severe.

At the first stage, all women underwent clinical examinations (inspection of the vagina and cervix in mirrors, bimanual gynecological examination, colposcopy), laboratory examinations (bacterioscopic examination of vaginal smears, evaluation of the degree of vaginal cleanliness).

During a gynecological examination, edema, hyperemia of the mucous membrane of the vagina and cervix were detected in combination with ECE detected colposcopically.

During the study, 23 (82.14%) women noted the complete disappearance of clinical symptoms of vulvovaginitis. After the end of the course of treatment, patients noted isolated cases of the presence of discharge, heartburn and itching in a minor degree of severity.

Table 1
Evaluation of subjective complaints in women of the examined groups before and after treatment, number (%)
The severity of colpitis symptoms before treatment after treatment
itching heartburn discomfort during sexual life profuse discharge itching heartburn discomfort during sexual life profuse discharge
Slight severity
(1 point)
4 (14.2) 15 (53.5) 10 (35.7) 2 (7.1)* 1 (3.5)* 2 (7.1)* 3 (10.7)*
Moderate severity
(2 points)
4 (14.2) 15 (53.5) 10 (35.7) 2 (7.1)* 1 (3.5)* 2 (7.1)* 3 (10.7)*
Significant expression
(3 points)
4 (14.2) 15 (53.5) 10 (35.7) 2 (7.1)* 1 (3.5)* 2 (7.1)* 3 (10.7)*
* - the difference is significant relative to the indicator before treatment (p < 0.05);

Using microscopy of the urogenital smear, all women showed an increased number of leukocytes, abundant or moderate coccal and rod-shaped flora, specific microflora was not detected, Dederlein's rods were absent or present in small quantities. Thus, before the start of treatment, 18 (64.3%) patients had the III degree of vaginal cleanliness, 10 (35.7%) - the IV degree of vaginal cleanliness. After treatment, 2 (7.1%) patients were diagnosed with the first degree of vaginal cleanliness, 23 (82.1%) patients with the second degree, and 3 (10.7%) with the third degree of vaginal cleanliness. (Table 2)

Table 2
The presence of different degrees of cleanliness of the vagina before and after treatment, number (%)
Vaginal cleanliness level Before treatment After treatment
I 2 (7.1)*
II 23 (82.1)*
III 18 (64.3)
IV 10 (35.7)
* - the difference is significant relative to the indicator before treatment (p < 0.05);

During colposcopy, the patients showed signs of an inflammatory process of varying severity, as well as ECE in the first zone

After treatment, there was a reduction in the ECE zone, as well as an incomplete zone of benign transformation (IZBT) in 12 (42.9%) patients, as well as a complete zone of benign transformation (CZBT) and a normal colposcopic picture in 7 (25%) patients, which indicates the stimulation of epithelialization processes (Table 3).

Table 3
Evaluation of the colposcopic picture before and after treatment, number (%)
Before treatment After treatment
Cervicitis ECE Cervicitis ECE IZBT CZBT, normal colposcopic picture
26 (92.8) 24 (85.7) 9 (32.1)* 12 (42.9)* 7 (25)*
* - the difference is significant relative to the indicator before treatment (p < 0.05);

Tolerability of treatment was assessed by the researcher as good in 93%, by the patient - in 89%. This indicates a good tolerability of the API-NORM drug, it practically does not affect the general condition of patients (Table 4). Among the side effects, itching was observed in one patient, and heartburn in the vagina in another. At the same time, hyperemia of the vaginal mucosa was noted by the researcher in one case.

Table 4
Assessment of tolerability of API-NORM suppositories, amount (%)
Tolerability of the drug Assessment by researcher Assessment by the patient
Good 26 (92.9) 25 (89.3)
Satisfactory 2 (7.1) 3 (10.7)


Conducted clinical trials of API-NORM suppositories testify to its high clinical effectiveness in the treatment of non-specific vaginitis, as well as improvement in the process of epithelialization of ectopy of the cylindrical epithelium, absence of adverse reactions and good tolerability, which makes it possible to recommend it for use in complex therapy of non-specific vaginitis. as well as in the treatment of ectopy of the cylindrical epithelium against the background of non-specific vaginitis.