Dark Chocolate, Coconut Water, and Ibuprofen in Managing Primary Dysmenorrhea

Dysmenorrhea Primary Clinical Trial

Official title:

Single-Blinded Randomized Controlled Trial: Comparative Efficacy of Dark Chocolate, Coconut Water, and Ibuprofen in Managing Primary Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05971186
• Other study ID #: 703/UN6.KEP/EC/2022
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Dysmenorrhea Primary
• Ibuprofen
• Menstrual Pain

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