Design: a multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of study treatment.~The study will enroll the schoolchilds of either gender of grades 1, 2 and 3 of a regular school aged 7-9 years old (grade 1 schoolchilds will be enrolled at the beginning of the second half of the year) complaining of difficult learning classified according to ICD-10 as specific developmental disorders of scholastic skills (F81) including:~specific reading disorder (F81.0); specific spelling disorder (F81.1); specific disorder of arithmetical skills (F81.2); mixed disorder of scholastic skills (F81.3; disorder simultaneously meeting criteria of F81.2+F81.0 or F81.2+F81.1 or F81.2+F81.0+F81.1).~The schoolchilds will be examined for developmental disorders of scholastic skills by a pediatrician (either a neurologist or psychiatrist) as well as by administering speech-language/psychological/educational tests. The children may have any background (underlying) diseases not considered as exclusion criteria and not requiring pharmacotherapy during the following 12 weeks using the products specified in section Forbidden concomitant therapy. Correction pedagogic events should not be performed within 12 weeks post enrollment either.~After signing information sheet (informed consent form) by the parent/adopter the patoients will be examined by a neurologist or psychiatrist and tested for reading skills (method by L.A. Fotekova, Т.V. Akhutina, 2002; Appendix 1), writing skills (method by L.A. Fotekova, Т.V. Akhutina, 2002; Appendix 2) and counting skills (subtest No. 3 Arithmetic WISC subtest; Appendix 3), and concomitant therapy will be recorded.~If inclusion criteria are met and non-inclusion criteria are absent at Visit 1, the patient will be enrolled in the trial and randomized into one of the two groups: 1 tablet of Tenoten for children three times daily for 3 months (group 1) or the same dosing regimen of Placebo (group 2).~At Visit 1 the parents/adopters will receive the study product for 12-week treatment period and a diary to report any potential adverse events and cases of concomitant therapy.~Six weeks later (Week 6±3 days) a Phone visit (Visit 2) will be made to inquire on the subject's health, presence/absence of concomitant diseases, adverse events against the treatment.~At Visit 3 (Week 12±3 days) retesting of reading, writing and counting skills will be made, complaints, data on concomitant diseases, concomitant therapy and adverse events will be collected. The investigator will evaluate the subject's compliance and fill clinical global impression scale (CGI-EI).~Therapy of co-morbidities is allowed during the study except for the products specified in section Forbidden concomitant therapy.
Purpose of the study:~To assess efficacy of Tenoten for children® in children with specific developmental disorders of scholastic skills.~To assess safety of Tenoten for children® in children with specific developmental disorders of scholastic skills.