Comparision of efficacy of PRHgh ( Daroopakhsh, Iran ) and Norditropin (Novo -Nordisk, Denmark) on growth of short stature children with Growth Hormone deficiency

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201206054794N5

Enrollment

Registered

2012-09-11

Start date

2012-10-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency. (E23.0 Hypopituitarism(isolated GH deficiency

Interventions

This double blind RCT will be done on short stature and GH deficient children in Tehran to compare the efficacy of new Iranian GH drug (PrhGH, Daroupakhsh) and Norditropin (Novo-Nordisk, Denmark). Chi

Treatment - Drugs

This double blind RCT will be done on short stature and GH deficient children in Tehran to compare the efficacy of new Iranian GH drug (PrhGH, Daroupakhsh) and Norditropin (Novo-Nordisk, Denmark). Ch

Eligibility

Sex/Gender

All

Age

2 Years to 14 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:I- Children>2y and in pre-pubertal stage (Tanner 1-2) with A- short stature:1- Height > 2SD below the mean of age and sex or 2- Target height > 2 SD below MPH or 3- Height tanner2); 2- Chronic systemic disorders, hypothyroidism, Celiac, Skeletal dysplasia, chronic renal disease, Chromosomal abnormalities. Omit from the study: 1- Starting puberty; 2- More than two weeks GH therapy withdrawal; 3- No interest to follow up.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Height. Timepoint: every 3 months. Method of measurement: stediometer (cm).;Growth velocity. Timepoint: every 3 months. Method of measurement: cm/mo.;Ht SDS. Timepoint: every 3 months. Method of measurement: (Ht patient- Ht 50% )/ Ht SD.	—

Secondary

Measure	Time frame
TFT. Timepoint: every 3 months. Method of measurement: Blood test.;IGF-I. Timepoint: every 3 months. Method of measurement: Blood test.;Weight,. Timepoint: every 3 months. Method of measurement: Scale (Kg).;FPG. Timepoint: every 3 months. Method of measurement: Blood test.;CBC. Timepoint: every 3 months. Method of measurement: Blood test.;Bone age. Timepoint: every 6 months. Method of measurement: Left hand radiography.	—

Measure

Time frame

TFT. Timepoint: every 3 months. Method of measurement: Blood test.;IGF-I. Timepoint: every 3 months. Method of measurement: Blood test.;Weight,. Timepoint: every 3 months. Method of measurement: Scale (Kg).;FPG. Timepoint: every 3 months. Method of measurement: Blood test.;CBC. Timepoint: every 3 months. Method of measurement: Blood test.;Bone age. Timepoint: every 6 months. Method of measurement: Left hand radiography.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Peymaneh Sarkhail

Endocrine Research Center

peymaneh999@gmail.com+98 21 2243 2500

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026