Impact of Ginger on Menopausal Symptoms

NCT05499793 | Completed DMC

• 1 other identifier: 24102021-10-36
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Outcome Measures

Primary Outcomes (4)

• Impact of Zingiber Officinale on hot flush in menopausal women

  A significant change in the intensity of hot flushes was observed in the menopausal rating scale in menopausal women treated with ginger powder compared to pre-treatment.

  six weeks treatment with Zingiber Officinale powder

• Impact of Zingiber Officinale on Night sweating in menopausal women

  A significant change in the intensity of night sweating was observed in the menopausal rating scale in menopausal women treated with ginger powder compared to pre-treatment.

  six weeks treatment with Zingiber Officinale powder

• Impact of Zingiber Officinale on estrogen levels in menopausal women

  A significant change was observed in serum estrogen levels in menopausal women treated with ginger powder compared to pre-treatment.

  six weeks treatment with Zingiber Officinale powder

• Impact of Zingiber Officinale on body weight in menopausal symptoms

  A significant change was observed in body weight in kilograms in menopausal women treated with ginger powder compared to pre-treatment.

  six weeks treatment with Zingiber Officinale powder

Study Arms (2)

Treatment group (Ginger)

EXPERIMENTAL

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)

Dietary Supplement: Zingiber Officinale powder

Control group (Placebo)

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Zingiber Officinale powder DIETARY_SUPPLEMENT

Ginger powder

Also known as: Ginger

Treatment group (Ginger)

Placebo DIETARY_SUPPLEMENT

Starch powder

Also known as: control

Control group (Placebo)

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Duhok: lead

Study Sites (1)

University of Duhok College of Pharmacy

Duhok, Kurdistan Region, 42001, Iraq

Location

MeSH Terms

Interventions

ginger extract

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A pharmacist professional was responsible for distributing the treatment (ginger) and placebo and he was in charge to assign the participants to the groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Student in clinical Pharmacology

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 12, 2022
• Study Start: December 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)