MenopauseNCT06716554
Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
A study testing Shatavari extract and Shatavari + Ashwagandha extract in people with Menopause and Hot Flashes, run by SF Research Institute, Inc. at 1 site in United States.
Trial summary
This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari for the treatment of Menopausal symptoms in Women. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Hot Flashes, Mood
- What is being tested?
- Shatavari extract and Shatavari + Ashwagandha extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2024to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Menopausal women aged 45 to 65 years with intact uterus and ovaries.
- Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days
- Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
- Body mass index 18-35 kg/m2
- Subject who has given written informed consent to participate in the study and understand the nature of the study
- Able to read and write in English or any other vernacular language
- No plan to commence new treatments over the study period.
- Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
Who cannot join
- Participants taking any form of herbal extract in the last 3 months before study entry.
- Participants who are on hormone replacement therapy (HRT) for more than 3 months.
- Participants with Present active medical, surgical, and gynaecological problems.
- Participants with a history of alcohol, tobacco dependence, or any substance abuse
- Participants who had undergone bilateral ovariectomy
- Participants with history of breast or cervical carcinoma
Show all 15Show fewer
- Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate.
- Participants with Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult
- Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Participants with evidence of uncooperative attitude, including poor compliance.
- Participants with inability to attend follow-up visit
- Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective.
- Patients with known hypersensitivity to Ashwagandha.
- Patients who had participated in other clinical trials during the previous 3 months.
- Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
SF Research Institute, Inc.
San Francisco, California, 94127
John Ademola, 415-845-4638, jademola@sfinstitute.com
About this study
This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari for the treatment of Menopausal symptoms in Women. Participants will be randomized to either one of the three treatment arms.Participants will then be asked to either take one capsule containing Shatavari or Shatavari + Ashwagandha or Placebo orally once daily in the morning after breakfast with a glass of water for 8 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. The primary objective is to compare the efficacy of shatavari for treatment of menopausal symptoms in women. The secondary objective is to compare the safety of shatavari for treatment of menopausal symptoms in women.
Read the detailed description
To qualify for the study, participants must be menopausal women aged 45 to 65 years with intact uterus and ovaries. Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days. Women with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
In this study, a maximum of 51 patients will be enrolled and the goal is to complete the study with at least 45 patients.
After signing this consent form, participants will answer questions regarding their medical history, including any medications they are taking. Physical exams with vital signs (pulse, temperature, sitting blood pressure and respiratory rate) will be performed at both visits by a professional trained to perform this testing.
It may be a Nurse (RN or LPN), Phlebotomist, or Medical Doctor. In order to be qualified to participate this study at initial Visit (Baseline), BMI score range between 18-35 are required.
A blood sample will be required from subjects. Subject's right or left arm will be used as the blood draw site, requiring a 5mL sample. The blood will be analyzing Sr. Estradiol, FSH, LH, Testosterone levels. These blood draws will be administered by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist or Medical Doctor.
All eligible participants, will be given the required quantity of the study medication for self-administration, sufficient till the Visit 3- End of study visit, 8 weeks ± 4 Days. Participants will be randomized to either one of the three treatment arms.
Participants will be instructed to take one capsule of study medication to which they are randomized after breakfast, with ambient temperature water for 8 weeks at home. Participants will be asked to visit the site for Visit 2 (4 weeks ± 4 Days), Visit 3 (8 weeks ± 4 Days). Adverse events and concomitant medication will be recorded throughout the study. Participants will be asked to get used and unused study medications and their subject diaries in this visit. All the participants will be asked to continue their routine diet and physical activities during the whole study period.
The primary end point is the mean change in score for Menopause Rating Scale (MRS) from baseline. And the secondary end points are mean changes in scores for Perceived Stress Scale (PSS) questionnaire, Menopause Symptoms Treatment Questionnaire (MENQOL) scores, Profile of Mood States (POMS, abbreviated version) and mean changes in Serum hormones (Sr. Estradiol, FSH, LH, Testosterone) levels from baseline.
- Conditions
- Menopause, Hot Flashes, Mood
- Being tested
- Shatavari extract, Shatavari + Ashwagandha extract, Placebo
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shatavari extractDietary supplement
Shatavari is scientifically known as Asparagus racemosus. One capsule containing Shatavari 300mg should be taken once daily.
Shatavari + Ashwagandha extractDietary supplement
Shatavari is scientifically known as Asparagus racemosus along with Ashwagandha root extract scientifically known as Withania somnifera. One capsule containing Shatavari 300mg + Ashwagandha root extract 250mg should be taken once daily.
PlaceboDietary supplement
Placebo (starch)
| Study group | Role | What they receive |
|---|---|---|
| Shatavari | Experimental | One capsule of Shatavari 300 mg (contains Shatavari extract) once a day, orally with water. Receives: Dietary Supplement: Shatavari extract |
| Shatavari + Ashwagandha | Experimental | One capsule of Shatavari (300mg) + Ashwagandha (250mg) (contains Shatavari + Ashwagandha root extract) once a day, orally with water. Receives: Dietary Supplement: Shatavari + Ashwagandha extract |
| Placebo | Placebo comparator | One capsule of Placebo 300 mg (contains starch extract) once a day, orally with water. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause Rating Scale (MRS)
The scale consisted of 11 items, ranging from no symptoms to very severe symptoms. The total score of the MRS ranges from 0 (asymptomatic) to 44 (highest degree of complaints). The minimal/maximal scores vary between the three dimensions, depending on the number of complaints allocated to the respective dimension of symptoms.
Measured: MRS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8).
Secondary outcomes (4)
Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS-10) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes several direct queries about current levels of experienced stress. The questions in the PSS ask about feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way
Measured: PSS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), Visit 3 End of study visit, (Week 8).
Menopause-Specific Quality of Life Questionnaire (MENQOL)
The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale.
Measured: MENQOL assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), Visit 3 End of study visit, (Week 8).
Profile of Mood States (POMS, abbreviated version)
The POMS is a 40-item questionnaire rated on a 5-point Likert Scale, asking respondents how they feel right now. Scores are calculated for Tension, Anger, Fatigue, Depression, Esteem- related affect, Vigor, Confusion, and Total Mood Disturbance.
Measured: POMS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), Visit 3 End of study visit, (Week 8).
Serum Hormones
Measured: Blood samples for Serum hormones (Sr. Estradiol, FSH, LH, Testosterone) will be collected at Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) and Visit 3- (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start26 Oct 2024
- Primary completion26 Dec 2024 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Collaborators
- Ixoreal Biomed Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716554
- Sponsor's protocol ID
- SHT-1076-2024-1
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ademola J, Ajgaonkar A, Debnath T, Debnath K, Langade J. Efficacy and safety of Shatavari root extract (Asparagus racemosus) for menopausal symptoms: a randomized, double-blind, three-arm, placebo-controlled study. Front Reprod Health. 2025 Nov 27;7:1654503. doi: 10.3389/frph.2025.1654503. eCollection 2025.
PubMed 41394012
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06716554
- Acronym / sponsor ID
- SHT-1076-2024-1
- Conditions
- Menopause, Hot Flashes, Mood
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- SF Research Institute, Inc.Research network
- Collaborators
- Ixoreal Biomed Inc.
- Study start
- 26 Oct 2024 (actual)
- Primary completion
- 26 Dec 2024 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 4 Dec 2024 (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 is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari for the treatment of Menopausal symptoms in Women. Participants will be randomized to either one of the three treatment arms.Participants will then be asked to either take one capsule containing Shatavari or Shatavari + Ashwagandha or Placebo orally once daily in the morning after breakfast with a glass of water for 8 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. The primary objective is to compare the efficacy of shatavari for treatment of menopausal symptoms in women. The secondary objective is to compare the safety of shatavari for treatment of menopausal symptoms in women.
Detailed description
To qualify for the study, participants must be menopausal women aged 45 to 65 years with intact uterus and ovaries. Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days. Women with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
In this study, a maximum of 51 patients will be enrolled and the goal is to complete the study with at least 45 patients.
After signing this consent form, participants will answer questions regarding their medical history, including any medications they are taking. Physical exams with vital signs (pulse, temperature, sitting blood pressure and respiratory rate) will be performed at both visits by a professional trained to perform this testing.
It may be a Nurse (RN or LPN), Phlebotomist, or Medical Doctor. In order to be qualified to participate this study at initial Visit (Baseline), BMI score range between 18-35 are required.
A blood sample will be required from subjects. Subject's right or left arm will be used as the blood draw site, requiring a 5mL sample. The blood will be analyzing Sr. Estradiol, FSH, LH, Testosterone levels. These blood draws will be administered by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist or Medical Doctor.
All eligible participants, will be given the required quantity of the study medication for self-administration, sufficient till the Visit 3- End of study visit, 8 weeks ± 4 Days. Participants will be randomized to either one of the three treatment arms.
Participants will be instructed to take one capsule of study medication to which they are randomized after breakfast, with ambient temperature water for 8 weeks at home. Participants will be asked to visit the site for Visit 2 (4 weeks ± 4 Days), Visit 3 (8 weeks ± 4 Days). Adverse events and concomitant medication will be recorded throughout the study. Participants will be asked to get used and unused study medications and their subject diaries in this visit. All the participants will be asked to continue their routine diet and physical activities during the whole study period.
The primary end point is the mean change in score for Menopause Rating Scale (MRS) from baseline. And the secondary end points are mean changes in scores for Perceived Stress Scale (PSS) questionnaire, Menopause Symptoms Treatment Questionnaire (MENQOL) scores, Profile of Mood States (POMS, abbreviated version) and mean changes in Serum hormones (Sr. Estradiol, FSH, LH, Testosterone) levels from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shatavari | Experimental | Dietary Supplement: Shatavari extractOne capsule of Shatavari 300 mg (contains Shatavari extract) once a day, orally with water. |
| Shatavari + Ashwagandha | Experimental | Dietary Supplement: Shatavari + Ashwagandha extractOne capsule of Shatavari (300mg) + Ashwagandha (250mg) (contains Shatavari + Ashwagandha root extract) once a day, orally with water. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne capsule of Placebo 300 mg (contains starch extract) once a day, orally with water. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Menopausal women aged 45 to 65 years with intact uterus and ovaries.
- Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days
- Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
- Body mass index 18-35 kg/m2
- Subject who has given written informed consent to participate in the study and understand the nature of the study
Key exclusion criteria (15 listed)
- Participants taking any form of herbal extract in the last 3 months before study entry.
- Participants who are on hormone replacement therapy (HRT) for more than 3 months.
- Participants with Present active medical, surgical, and gynaecological problems.
- Participants with a history of alcohol, tobacco dependence, or any substance abuse
- Participants who had undergone bilateral ovariectomy
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 |
|---|---|---|
| Shatavari extractShatavari is scientifically known as Asparagus racemosus. One capsule containing Shatavari 300mg should be taken once daily. | Dietary supplement | Shatavari |
| Shatavari + Ashwagandha extractShatavari is scientifically known as Asparagus racemosus along with Ashwagandha root extract scientifically known as Withania somnifera. One capsule containing Shatavari 300mg + Ashwagandha root extract 250mg should be taken once daily. | Dietary supplement | Shatavari + Ashwagandha |
| PlaceboPlacebo (starch) | Dietary supplement | Placebo |
Primary outcome
Menopause Rating Scale (MRS)
Time frame: MRS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8).
The scale consisted of 11 items, ranging from no symptoms to very severe symptoms. The total score of the MRS ranges from 0 (asymptomatic) to 44 (highest degree of complaints). The minimal/maximal scores vary between the three dimensions, depending on the number of complaints allocated to the respective dimension of symptoms.
4 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: PSS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), Visit 3 End of study visit, (Week 8).
Menopause-Specific Quality of Life Questionnaire (MENQOL)
Time frame: MENQOL assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), Visit 3 End of study visit, (Week 8).
Profile of Mood States (POMS, abbreviated version)
Time frame: POMS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), Visit 3 End of study visit, (Week 8).
Serum Hormones
Time frame: Blood samples for Serum hormones (Sr. Estradiol, FSH, LH, Testosterone) will be collected at Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) and Visit 3- (Week 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 41394012Ademola J, Ajgaonkar A, Debnath T, Debnath K, Langade J. Efficacy and safety of Shatavari root extract (Asparagus racemosus) for menopausal symptoms: a randomized, double-blind, three-arm, placebo-controlled study. Front Reprod Health. 2025 Nov 27;7:1654503. doi: 10.3389/frph.2025.1654503. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shatavari extract and Shatavari + Ashwagandha extract in people with Menopause and Hot Flashes, run by SF Research Institute, Inc. at 1 site in United States.
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 8 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 4 Dec 2024. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khaleeq Rehman (+1 (415) 690-9641, khaleeqr.sfinstitute@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause Rating Scale (MRS) (time frame: MRS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06716554, which also lists 1 linked publication.
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 4 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.