Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05971186 |
Other study ID # |
703/UN6.KEP/EC/2022 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
June 30, 2022 |
Est. completion date |
August 15, 2022 |
Study information
Verified date |
August 2023 |
Source |
Universitas Padjadjaran |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Dysmenorrhea, the painful condition experienced by women during menstruation, affects a
significant proportion of women worldwide and often leads to decreased productivity. Various
pharmacological and non-pharmacological treatments are available for pain relief, but
information on their effectiveness, particularly regarding green coconut water, dark
chocolate, and Ibuprofen, remains limited. This study aimed to compare the effectiveness of
green coconut water, dark chocolate bars, and Ibuprofen in reducing the intensity of primary
dysmenorrhea. A randomized controlled trial with a quantitative design was conducted,
involving 45 participants randomly assigned to receive either 330 ml of green coconut water,
35 grams of 70% dark chocolate, or 400 mg Ibuprofen. Pain intensity was measured before and
after treatment.
Description:
Dysmenorrhea, commonly known as period pain, is a prevalent condition that affects a large
number of women during menstruation, causing discomfort and often leading to reduced
productivity. While several treatments are available to alleviate the pain, there is limited
information on the comparative effectiveness of different interventions, including green
coconut water, dark chocolate, and Ibuprofen.
This research aimed to conduct a randomized controlled trial to compare the effectiveness of
green coconut water, dark chocolate bars, and Ibuprofen in managing primary dysmenorrhea. A
total of 45 participants were enrolled in the study and randomly assigned to one of three
intervention groups: green coconut water, dark chocolate bars, or Ibuprofen.
The green coconut water group received 330 ml of pure green coconut water, which is known for
its potential health benefits and natural electrolyte content. The dark chocolate group
received 35 grams of 70% dark chocolate, as some studies have suggested its potential role in
pain relief due to the presence of bioactive compounds. The Ibuprofen group received 400 mg
of the common over-the-counter nonsteroidal anti-inflammatory drug (NSAID) known for its
analgesic properties.
To assess the effectiveness of each intervention, pain intensity was measured before and
after treatment using validated pain scales. The Kruskal-Wallis test, a non-parametric
statistical method, was used to analyze the data and compare the effectiveness of the three
interventions.