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Table 1 The analysis of the 26 publications matching the search criteria

From: Unapproved clinical trials in Russia: exception or norm?

No

Journal article

Approved indications

Approved conditions of use

Clinical trial approved by the MoH

Randomisation

Advertising

Duplication

1

Comparison of clinical efficacy and safety of the two drugs in the therapy of symptoms of eruption of infant teeth (“Dantinorm Baby®” vs “Calgel®””) [10]

+

+

+

+

2

Nonsteroid anti-inflammatory drugs for the treatement of osteoarthrosis: comparative efficacy and tolerability of nimesulide [11]

+

+

+

+

3

Efficiency of butyric acid and inulin in patients with irritable bowels syndrome: results of multicenter study [12]

+

+

4

Efficiency of different schemes of antihelicbacter therapy in patients with chronic gastroduodenal diseases and type 2 diabetes mellitus [13]

No. 12

5

Enterosorption in the treatment of duodenal ulcer in children in the settings of Helicobacter pylori infection and Candida colonization [14]

+

No. 24

6

Antihypertensive efficacy of chronopharmacotherapeutical approach to arterial hypertension in post transient ischemic attack patients [15]

+

+

+

+

7

Evaluation of the Reactogenicity, Safety and Immunogenicity of the Domestic Influenza Inactivated Split FLU-M Vaccine in Immunization Adults aged 18-60 Years [16]

+

+

+

+

8

Vitabact in the treatment of inflammatory diseases of eyes in the conditions of neuro reanimation [17]

+

9

Open prospective randomized study of the results of using Venarus in postthrombotic disease [18]

+

+

+

+

10

Clinical evaluation of the efficacy of azoxime boviolaluronidase in the prevention of excessive scarring after surgical treatment of glaucoma [19]

+

+

11

Study of clinical efficacy of original and generic drugs of ivabradine in patients with stable angina (comparative study)[20]

+

+

?

+

+

12

New aspects of eradicative anti-helicobacter pylori in type 2 diabetic patients with chronic gastroduodenal disorders [21]

No. 4

13

Estimation of hypolipidemic psillium effect in gastroenterologic patients with lipid metabolism disorders [22]

14

The inhalation therapy of moderate forms of acute bacterial rhinosinusitis [23]

+

+

15

Experience of the usage of Tonsilgon® N in the complex treatment of chronic tonsillitis with irrigations of palatine tonsils in adults [24]

+

+

+

+

16

Efficiency and safety of chemotherapy regimen with SQ109 in those suffering [25]

+

+

+

17

Anhedonia, depression, anxiety, and craving in opioid dependent patients stabilized on oral naltrexone or naltrexone implant [26]

+

+

+

18

Alcohol withdrawal syndrome dynamics during treatment with Nooclerin (deanoli aceglumas) [27]

+

+

+

+

19

Indicators’ dynamics of electrophysiological non-homogeneity of myocardium on the patients’ intensive statinology in postinfarctic period [28]

+

 − 

−/+

20

Results of the intermittent regimen of initial pain therapy with chondroitin sulfate and glucosamine sulfate for patients with osteoarthritis, back pain and comorbidity [29]

+

+

+

+

21

Observational study of the efficiency and safety of the use of tenoxicam in dorsalgy in comparison with meloxicam and [30]

+

+

+

+

22

Evaluation of efficacy and safety of rebamipide use in the triple therapy for Helicobacter pylori eradication: a pilot study [31]

+

+

+

+

23

Immunogenicity of the third generation hepatitis b vaccine (pre-S1/pre-S2/S) [32]

+

+

24

Enterosorption in the treatment of duodenal ulcer in children in the settings of helicobacter pylori infection and candida colonization [33]

+

+

No. 5

25

Effectiveness of the tenoxicam in patients with ankylosing spondylitis [34]

+

+

+

26

Efficiency of combined antihypertensive therapy in patients with arterial hypertension and obesity depending on the polymorphism of CYP2C9 gene [35]

+

+

−/+

  1. We used the original English titles and did not correct the spelling. Column "Randomisation" can contain "+" for a clinical trial that was randomised, “−" for a clinical trial claimed to be randomised while in fact it was not, "+/−" if the randomisation was not related to the objectives of the study and the results obtained. In all studies except No. 3, 16, 23 the medicinal product of interest was approved for marketing in Russia. “Duplication” column shows if the same results at least partially were reported in another article