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Homoeopathic medicinal product (known as Kindival in India) in children with sleep disorder and restlessness

The study was designed as a prospective, multicenter, randomized, open-label, comparative, and controlled. The duration of study was 28 days. The five centers included the Children City Clinical Hospital No. 13 of the State Educational Institution for Higher Professional Education (Russian State Medical University), the Children City Poly Clinic No. 86 of the State Educational Institution for Additional Professional Education (Russian Medical Academy of Postgraduational Education), and the Federal State Institution in Moscow, the Children Regional Clinical Hospital 30V of the State Educational Institution for Higher Professional Education in Smolensk, and the State Educational Institution for Higher Professional Education in Yaroslavl, Russia.

Criteria for selection of patients was: 1. children of both genders, 2. who are up to six years of age, and 3. who have sleep disorders which manifested in difficulties falling asleep and maintaining sleep, present for at least one month prior to study start. Sleep disorders should not be associated with somatic or psychic diseases and intracranial hypertension or in case of severe concomitant diseases. Number of Patients was 180, 90 allotted for Kindival, containing each tablet of 100 mg contains: Cypripedium pubescens 4x 15mg; Magnesia carbonica 10x 20mg; Zincum valerianicum 12x 15mg, “X = D”) group and 90 for controlled (Glycine 100mg) group.

Results:

  1. The Kindival group, the total complaints severity score decreased from median 7.0 points at baseline to 2.0 points at day 28 of treatment (V4).
  2. A decrease in the total complaints severity score was also observed in the control group but less pronounced at day 28.
  3. For the overall treatment related difference on odds ratio of 4.45 was found, indicating that children in the Kindival group had higher odds of showing improvement than those in the control group.
  4. Similar significant differences in favour of Kindival were found at day 14 (V3) and day 28 (V4) of treatment.
  5. Higher percentage of children in the Kindival group had no complaints at study end.
  6. Odds of showing responsiveness defined as “absence of all complaints” than those in the control group.
  7. In the Kindival group reduction in complaints by at least 50%, a significant higher percentage of responders were found, compared to the control group at the end of study.
  8. Reduction in number of present complaints of at least 50% compared to baseline.
  9. Significant difference in proportion in favour of Kindival was found for the individual complaints “time to sleep onset”, “ troubled sleep, somniloquism”, and “sleep disorders frequency”.

 

 

 

 

 

Figure 1: Treatment satisfaction assessments by children/parents by means of IMPSS. IMPSS: IntegrativeMedicine Patient Satisfaction Scale, assessment at study end (V4, day 28, final overall evaluation). Intention-to-treat analysis.


Table: Tolerability assessment by investigator and children/parents. Measurements at V4 (day 28) in the final overall evaluation. Intention-to-treat analysis.

 

Investigator’s assessment

Children’s/parents’ assessment

Assessment of tolerability

Kindival

???? = 89

Control

???? = 90

Kindival

???? = 89

Control

???? = 90

N

%

N

%

N

%

N

%

Very good

63

70.8

59

65.6

62

69.7

58

64.4

Good

25

28.1

25

27.8

26

29.2

26

28.9

Satisfactory

0

0.0

6

6.7

0

0.0

6

6.7

Poor

1

1.1

0

0.0

1

1.1

0

0.0

                   

 

It was concluded by the researchers that treatment with Kindival was found to be safe and effective in the treatment of sleep disorders in children.

Reference: Miek C. Jong, Lydia Ilyenko, Irina Kholodova, Cynthia Verwer, Julia Burkart, StephanWeber, Thomas Keller, and Petra Klement; A Comparative Randomized Controlled Clinical Trial on the Effectiveness, Safety, and Tolerability of a Homeopathic Medicinal Product in Children with SleepDisorders and Restlessness. Evidence-Based Complementary and Alternative Medicine, Volume 2016 (2016), Article ID 9539030, 11 pages.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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