MenopauseNCT05499793
Impact of Ginger on Menopausal Symptoms
A study testing Zingiber Officinale powder in people with Menopause, run by University of Duhok at 1 site in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Zingiber Officinale powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIraq
- Study dates
- 1 Dec 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women living in Duhok city with self-reported menopause symptoms
- Aged between 45 and 60 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iraq1 site
University of Duhok College of Pharmacy
Duhok, Kurdistan Region, 42001
About this study
Official title: Impact of Zingiber Officinale on Symptoms and Hormonal Changes During the Menopausal Period in Duhok -Iraq
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.
Read the 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
- Being tested
- Zingiber Officinale powder, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zingiber Officinale powderDietary supplement
Also called Ginger
Ginger powder
PlaceboDietary supplement
Also called control
Starch powder
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: six weeks treatment with Zingiber Officinale powder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Dec 2021
- Primary completion1 Mar 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Duhok
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niroosh Hashim Taha, University of Duhok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499793
- Sponsor's protocol ID
- 24102021-10-36
- Status last verified
- Aug 2022
- First submitted
- 7 Aug 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The collected Data will not be shared until the study has been published
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Zingiber Officinale on Symptoms and Hormonal Changes During the Menopausal Period in Duhok -Iraq
- ClinicalTrials.gov ID
- NCT05499793
- Acronym / sponsor ID
- 24102021-10-36
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of DuhokUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Treatment group (Ginger) | Experimental | Dietary Supplement: Zingiber Officinale powderAll 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) |
| Control group (Placebo) | Placebo comparator | Dietary Supplement: PlaceboAll the participants were given starch powder (50 mg) capsules twice daily for twelve weeks. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women living in Duhok city with self-reported menopause symptoms
- Aged between 45 and 60 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zingiber Officinale powderAlso: GingerGinger powder | Dietary supplement | Treatment group (Ginger) |
| PlaceboAlso: controlStarch powder | Dietary supplement | Control group (Placebo) |
Primary outcome
Impact of Zingiber Officinale on hot flush in menopausal women
Time frame: six weeks treatment with Zingiber Officinale powder
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.
Impact of Zingiber Officinale on Night sweating in menopausal women
Time frame: six weeks treatment with Zingiber Officinale powder
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.
Impact of Zingiber Officinale on estrogen levels in menopausal women
Time frame: six weeks treatment with Zingiber Officinale powder
A significant change was observed in serum estrogen levels in menopausal women treated with ginger powder compared to pre-treatment.
Impact of Zingiber Officinale on body weight in menopausal symptoms
Time frame: six weeks treatment with Zingiber Officinale powder
A significant change was observed in body weight in kilograms in menopausal women treated with ginger powder compared to pre-treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No. The collected Data will not be shared until the study has been published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zingiber Officinale powder in people with Menopause, run by University of Duhok at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Zingiber Officinale on hot flush in menopausal women (time frame: six weeks treatment with Zingiber Officinale powder). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.