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Rosa damascena together with brown sugar mitigate functional constipation in children over 12 months old: A double-blind randomized controlled trial.

  • 2022-08-10
  • Journal of ethnopharmacology 298
    • Mohammad Hadi Imanieh
    • Naser Honar
    • Abdolali Mohagheghzadeh
    • Mahmood Haghighat
    • Seyed Mohsen Dehghani
    • Ghazaleh Mosleh
    • Maryam Ataollahi
    • Heidar Safarpour
    • Behnaz Darban
    • Fereshteh Karbasian
    • Ali Reza Safarpour
    • Amir Hossein Hassani
    • Abbas Avazpour

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 100
Population
100 patients, children aged above 12 months with functional constipation
Methods
double-blind randomized clinical trial; one group received PEG, the other received a syrup made of decocted extract of 0.1 g R. damascena petals mixed with 0.85 g brown sugar per 1 mL
Blinding
Double-blind
Duration
two and four weeks
  • Large Human Trial

Ethnopharmacological relevance

Rosa × damascena Herrm., known as damask rose, is a bushy shrub that is found abundantly in Fars province, Iran. This species has been used in Iranian traditional practices for the treatment of abdominal pain and constipation, as gastrointestinal diseases. Brown sugar (Saccharum officinarum L.) has also shown laxative effects in pediatric patients with functional constipation.

Aim of study

This study aimed to compare the effects of Polyethylene Glycol (PEG) and a syrup made of R. damascena and brown sugar on the treatment of functional constipation in children aged above 12 months.

Materials and methods

This double-blind randomized clinical trial was performed on 100 patients. One group received PEG and the other received an herbal syrup containing the decocted extract of 0.1 g R. damascena petals mixed with 0.85 g brown sugar per 1 mL. The patients were followed up for two and four weeks and their progresses were recorded.

Results

The cure rate was 100% in the R. damascena group and 91.7% in the control group. R. damascena and brown sugar syrup had an odds ratio of 1.09 in the treatment of functional constipation compared to PEG, but the difference was not statistically significant. The only adverse effect detected in the R. damascena group after four weeks was the bad taste of the medication that was too sweet. Nonetheless, this could be solved during the pharmaceutical processes.

Conclusion

The R. damascena extract and brown sugar syrup can be used as an effective, safe, and inexpensive agent in the treatment of functional constipation.

Research Insights

  • Rose→Cured Constipation

    The cure rate was 100% in the R. damascena group and 91.7% in the control group. R. damascena and brown sugar syrup had an odds ratio of 1.09 in the treatment of functional constipation compared to PEG, but the difference was not statistically significant.

    Effect
    Neutral
    Effect size
    Small
    Dose
    0.1 g per mL of syrup

Adverse Events Reported

  • Rose→bad taste

    The only adverse effect detected in the R. damascena group after four weeks was the bad taste of the medication that was too sweet.

    Finding
    Reported
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