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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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date August 15, 2022
Est. primary completion date August 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 17 Years to 24 Years
Eligibility Inclusion Criteria: - Women aged between 17 and 24 years - Diagnosed with primary dysmenorrhea based on specific characteristics and assessment - Willing to refrain from using any pharmacological or non-pharmacological therapies other than the interventions provided by the researcher - willing to participate as respondents Exclusion Criteria: - Allergies to dark chocolate or young coconut water or contraindications to Ibuprofen consumption - Diagnosed with specific gynecological conditions.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ibuprofen 400 mg
Dosage Form: Tablet Dosage: 1 tablet of Ibuprofen (400 mg) Frequency: One-time consumption Duration: Pain intensity measured before consumption and two hours after consumption
Other:
Young Coconut Water
Dosage Form: Liquid (coconut water) Dosage: 330 ml (milliliters) of young coconut water Frequency: One-time consumption Duration: Pain intensity measured before consumption and two hours after consumption.
Dark Chocolate Bar
Dosage Form: Solid (dark chocolate bar) Dosage: 35 grams of 70% dark chocolate Frequency: One-time consumption Duration: Pain intensity measured before consumption and two hours after consumption.

Locations

Country Name City State
Indonesia Saleha Academy of Midwifery Banda Aceh Aceh

Sponsors (1)

Lead Sponsor Collaborator
Universitas Padjadjaran

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Intensity Pain intensity was measured using a Numeric Rating Scale (NRS) observation sheet, allowing respondents to rate their pain intensity on a scale from 0 to 10 The Pain intensity measured 2 times. Before the intervention and two hours after the intervention
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