CompletedPhase 1/2

Effectiveness of Recombinant Human Growth Hormone Therapy for Children With PMS

China6 participantsStarted 2020-06-14

Plain-language summary

In summary, this piot study with 6 participants shown that recombinant human growth hormone (rhGH) has a positive effect on the treatment with PMS. In addition, This study indicated that rhGH can improve PMS symptoms via increase the level of serum insulin-like growth factor-1 (IGF-1) and insulin-like growth factor binding protein 3 (IGFBP-3). RhGH may be low cost, more accessible, alternative treatment for PMS.

Who can participate

Age range1 Year – 5 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients diagnosed with PMS aged from 1years to 5 years Exclusion Criteria: \- active or suspected tumour, intracranial hypertension, chronic kidney disease, acute proliferative or severe nonproliferative diabetic retinopathy, allergy to rhGH or severe comorbidity

What they're measuring

level of serum IGF-1 and IGFBP-3

Timeframe: 3 months

Chinese version of the Gesell Development Scale (GDS)

Timeframe: 3 months

Simplified Chinese version of the Aberrant Behavior Checklist (SC-ABC)

Timeframe: 3 months

Adverse events

Timeframe: 3 months

Trial details

NCT IDNCT05105685

SponsorAffiliated Hospital of Jiangnan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-12

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