Impact of Ginger on Menopausal Symptoms

NCT ID: NCT05499793

Last Updated: 2022-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-06-01

Brief Summary

This study aimed to examine the impact of one gram of Zingiber Officinale powder on menopausal symptoms since a large number of menopausal women in this region (Duhok city in the North of Iraq) are reluctant to take the conventional treatment for improving their menopausal symptoms and they prefer of taking the ginger powder and surprisingly many of those patients reported positive effects on their symptoms and general well being.

Detailed Description

After taking the scientific and ethical approval from the College of the Pharmacy/ University of Duhok and the Directorate of Duhok Health (reference number 24102021-10-36) to look at the impact of Zingiber officinale on menopausal symptoms in women between 45 and 60 years old. A clinical interventional study was launched at the Gynecology Department in Azadi Teaching Hospital in Duhok Governorate, Iraq, from December 2021 to May 2022. This study initially recruited seventy women who matched the inclusion criteria. All the recruited women were informed about the study protocols, and they had the option to withdraw from it anytime. After giving written consent, they were randomly divided into one of two research groups through a random number generator software. Thirty-five women functioned as controls and were given placebo capsules for twelve weeks (A professional pharmacist formulated a 50mg starch purchased from the local market to look similar to the ginger capsule). The other thirty-five women were given pure Zingiber Officinale powder (500mg) in capsules twice daily for twelve weeks (Zingiber Officinale capsules were purchased from Pure Mountain Botanicals, 1712 Pioneer Ave # 1139 Cheyenne Wyoming 82001 (USA)). Twenty women completed the study in the placebo group, while thirty women completed the survey in the Ginger group. Unfortunately, fifteen participants from the control group and five women from the treatment group didn't finish the study and were excluded as they were not tighter to the project protocol.

The frequency and severity of menopausal symptoms were assessed using an internationally recognized questionnaire menopausal rating scale (MRS). Percentage differences between pre-treatment were compared to post-treatments.

The serum estrogen, progesterone, FSH, and LH levels were measured before and after treatment using a suitable kit for each hormone by Cobas e 411 analyzers (Roche Diagnostics).

Conditions

Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment group (Ginger)

All the participants were given Zingiber Officinale powder (500 mg) capsules twice daily for twelve weeks.

Zingiber Officinale capsules were purchased from Pure Mountain Botanicals, 1712 Pioneer Ave # 1139 Cheyenne Wyoming 82001 (USA)

Group Type: EXPERIMENTAL

Zingiber Officinale powder

Intervention Type: DIETARY_SUPPLEMENT

Ginger powder

Control group (Placebo)

All the participants were given starch powder (50 mg) capsules twice daily for twelve weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Starch powder

Interventions

Zingiber Officinale powder

Ginger powder

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Starch powder

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Ginger; control

Eligibility Criteria

Inclusion Criteria

• Women living in Duhok city with self-reported menopause symptoms
• Aged between 45 and 60 years

Exclusion Criteria

• Not on treatment for menopausal symptoms
• Patients Having chronic diseases like hypertension, Ischemic heart diseases or Diabetes mellitus
• Patients having coagulopathies
• Patient's having hormone-dependent malignancies

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Duhok

OTHER

Sponsor Role: lead

Responsible Party

Niroosh Hashim Taha

MSc Student in clinical Pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Duhok College of Pharmacy

Dihok, Kurdistan Region, Iraq

Countries

Iraq

Other Identifiers

24102021-10-36

Identifier Type: -

Identifier Source: org_study_id