Vasomotor SymptomsNCT07112651
Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause
A study testing CL25216 in people with Vasomotor Symptoms, run by ApexCPG LLC at 1 site in India.
Trial summary
This study is to evaluate the effects of CL25216 on vasomotor symptoms in women during Perimenopause. Enrolled subjects will receive either CL25216 - 250 mg/day or placebo. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Symptoms
- What is being tested?
- CL25216
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 24 Nov 2025to 12 Jun 2026
- 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 40 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy overweight women (BMI: 25-29 kg/m2) aged between 40 to 55 years with reports of changes in their menstrual cycle for at least 3 months.
- Participants needed to have a total score of greater than 16 on the Greene Climacteric Scale (GCS), have an intact uterus and ovaries.
- Early Perimenopausal Women according "The Stages of Reproductive Aging Workshop (STRAW) Classification (-2)" irregular periods without skipping menstrual cycles and more than seven days difference in length of consecutive cycles.
- Subjects with serum FSH >20 U/L on 3-5 days of menstrual cycle.
- Subjects with normal pelvic TVS and breast mammogram.
- Subjects with normal fasting blood glucose level (<125 mg/dl).
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- Subject understands the study procedures and provides signed informed consent to participate in the study.
- Subjects with normal blood thyroid profile.
- Females of childbearing potential who are sexually active must agree to use adequate contraception and can neither be pregnant nor lactating from screening throughout the duration of the study.
- Clinical screening including vital signs, electrocardiogram (ECG) and laboratory evaluations (including clinical chemistry, haematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
Who cannot join
- History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years, on anti-coagulant or anti-platelet drugs daily for any conditions.
- Subjects who had received hormonal treatment or any other herbal products in the previous 6 months.
- Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
- Subjects diagnosed with ovarian cysts ≥ 4 cm or any underlying pathology in pelvic ultrasonography (USG) performed during screening.
- Chronic or acute life stressors relating to a major life change, experiencing depression and/or receiving medication for such illness or disorders, receiving statins or other drugs known to impact on steroid hormone levels.
- Subjects having active gall bladder disease, gynaecological or breast surgery in the last 6 months.
Show all 19Show fewer
- History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years.
- Subjects with abnormal ECG.
- Pregnant and breast feeding female.
- History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products.
- Donation/loss of blood 1 unit or 350 mL within 90 days prior to receiving the first dose of study medication.
- Use of any recreational drugs (cocaine, amphetamine, barbiturates, benzodiazepines, cannabinoids, and morphine).
- History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
- Participated in a clinical study with an investigational drug or biologic within the last 30 days.
- Any condition that in opinion of the investigator, does not justify the subjects" participation in the study.
- Subjects with a high blood pressure at screening (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg).
- Subjects with progressive systemic diseases (e.g. tuberculosis, leucosis, collagenosis, multiple sclerosis, AIDS, HIV infections, Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or other auto-immune diseases).
- Evidence or history of clinically significant (in the judgment of the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.
- High alcohol intake (>2 standard drinks per day), smokers (>5 cigarettes per day).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects of CL25216 on Vasomotor Symptoms in Women During Perimenopause: a Randomised, Double-blind, Placebo-controlled Study
This study is to evaluate the effects of CL25216 on vasomotor symptoms in women during Perimenopause. Enrolled subjects will receive either CL25216 - 250 mg/day or placebo.
Read the detailed description
The purpose of this study is to evaluate the effects of CL25216 on vasomotor symptoms in women during perimenopause. A total of 80 female aged between40-55 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either CL25216 - 250 mg or placebo arms at 1:1ratio. The subjects will be instructed to take one capsule a day after breakfast for 105 days. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the CL25216 will also include routine laboratory investigations on blood, urine and clinical chemistry at Screening/Randomisation visit and the final visit of the intervention.
- Conditions
- Vasomotor Symptoms
- Being tested
- CL25216, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CL25216Dietary supplement
250mg to take one capsule a day after breakfast for 105 days
PlaceboDietary supplement
One capsule a day after breakfast for 105 days
| Study group | Role | What they receive |
|---|---|---|
| CL25216 | Experimental | 250 mg to take one capsule a day after breakfast for 105 days Receives: Dietary Supplement: CL25216 |
| Placebo | Other | One capsule a day after breakfast for 105 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to the end of the study period in: Scores of Greene Climacteric Scale (GCS)
The Greene Scale is a validated instrument designed to provide a concise assessment of menopause symptoms. It consists of 21 items, each measuring the severity of climacteric symptoms on a scale from 0 (none) to 3 (severe), where 1 indicates mild and 2 indicates moderate symptoms. The total score ranges from 0 to 63, with higher scores reflecting more severe climacteric symptoms.
Measured: Day 1, 35, 70, and 105
Secondary outcomes (19)
Change from baseline to the end of the study period in: GCS sub-scale psychological symptoms
Psychological score is calculated from 1 to 11 items of GCS, ranges from 0 - 33, with higher scores reflecting more severe climacteric symptoms.
Measured: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: GCS sub-scale scores: somatic/ physical symptoms
Somatic/ physical symptoms score is calculated from 12 to 18 items of GCS, ranges from 0 - 21, with higher scores reflecting more severe climacteric symptoms.
Measured: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: GCS sub-scale scores: vasomotor symptoms.
Vasomotor symptoms score is calculated from 19 to 21 items of GCS, ranges from 0 - 9, with higher scores reflecting more severe climacteric symptoms.
Measured: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Resting Metabolic Rate (RMR)
RMR reflects the caloric expenditure necessary for life, without accounting for physical activity or digestion, measured by using metabolic analyzer. Increase in RMR is a sign of improved metabolism
Measured: Day 1, and 105
Change from baseline to the end of the study period in: Positive and Negative Affect Schedule (PANAS-X)
The Positive and Negative Affect Schedule - Expanded Form (PANAS-X) is a validated self-report tool for assessing affective states, covering two broad dimensions: positive and negative affect. Each item has to be rated from 1 to 5 based on its severity. Each dimension is scored separately by summing the ratings of the individual items. As a result, the positive affect scale and the negative affect, with higher scores reflecting greater positive or negative affect, respectively.
Measured: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Quality of life questionnaire (Short Form -36)
The 36-Item Short Form (SF-36) is a self-reported questionnaire used to assess overall health and quality of life. It consists of 8 domains, each scored on a scale from 0 to 100. Higher scores indicate a better quality of life and improved health status.
Measured: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Sexual Function - Female Sexual Function Index (FSFI)
The FSFI was developed as a brief, easy-to-administer, self-report tool for assessing key dimensions or domains of sexual function and quality of life in various populations of women. Female Sexual Function Index (FSFI), a widely used tool with six domains (Arousal, Desire, Orgasm, Lubrication, Satisfaction, and Pain). The total FSFI score ranges from minimum score of 2 and maximum score of 36. Greater Scores indicates better sexual function
Measured: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: The Hot Flush Weekly Weighted Score (HFWWS)
HFWW Score is calculated from a scale measuring the frequency and severity of hot flushes experienced daily for a week. Lower scores indicates better resolution of hot flushes
Measured: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Bodyweight
The subject's body weight is measured using a digital weighing scale. An improvement is indicated when the body weight falls within the normal range based on the subject's demographic characteristics.
Measured: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: BMI
Body mass index is a calculated measure by considering the weight and height of a subject. A change in BMI from overweight to normal range is a positive indicator of healthy lifestyle.
Measured: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Scores of subjective self-assessments on hair quality
This is a subjective measurement of hair quality by considering the hair fall rate. The Highest Possible Score is 5.
Measured: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Skin wrinkle assessment
Visual assessment of skin wrinkles used to evaluate the appearance of skin aging and to determine the severity of wrinkles. This kind of assessment is typically done by a healthcare professional or dermatologist and involves examining the skin surface to identify and score wrinkles. Grade ranging from 0 to 9 where 0 represents no wrinkles and 9 represents deep wrinkles.
Measured: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Subject's self-assessment of skin Questionnaire
As the perception of the skin radiance is subjective, a self-assessment has been performed through a questionnaire. The scores range from 0 to 10, with higher scores indicating better skin quality in terms of complexion, smoothness, texture, elasticity, and hydration.
Measured: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Lipids
There is a clinically significant relationship between lipid metabolism and VMS like hot flashes and night sweats, especially in peri menopausal and postmenopausal women. Changes in lipid profiles may be both a cause and a consequence of hormonal shifts during this transition. Lower estrogen levels worsen lipid profiles and increases insulin resistance and central adiposity in perimenopusal/menopausal women.
Measured: Day 1, and 105
Change from baseline to the end of the study period in: HOMA-IR
HOMA-IR is a simple and widely used method to estimate insulin resistance (IR) in perimenopause/menopause. HOMA-IR can be useful in assessing cardio metabolic risk in menopausal or postmenopausal women, especially those with vasomotor symptoms, which sometimes correlate with increased metabolic risk.
Measured: Day 1, and 105
Change from baseline to the end of the study period in: FSH
It is a hormone produced by the pituitary gland and plays a crucial role in the reproductive systems of females. In perimenopause/menopause, the FSH level may rise disproportionately. Elevated FSH generally correlates with more frequent or severe hot flashes.
Measured: Day 1, and 105
Change from baseline to the end of the study period in: LH
It is a hormone made by the pituitary gland that plays a key role in the reproductive system of females. In perimenopause/menopause, LH secretion becomes irregular and elevated, with occasional surges. Chronically elevated LH levels are seen in menopause.
Measured: Day 1, and 105
Change from baseline to the end of the study period in: 17 beta-estradiol
17β-Estradiol (E2) is the most potent and biologically active form of estrogen in humans produced majorly by ovaries, followed by adrenal. Low estradiol is a key driver of VMS like hot flashes, night sweats, and sleep disturbances.
Measured: Day 1, and 105
Change from baseline to the end of the study period in: AMH
AMH (Anti-Müllerian Hormone) is a marker of ovarian reserve, reflecting the number of remaining follicles in the ovaries. Levels decline with age and become undetectable at menopause. AMH testing could help identify women at risk for early and intense vasomotor symptoms.
Measured: Day 1, and 105
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start24 Nov 2025 (estimated)
- Primary completion12 Jun 2026 (estimated)
- Study completion12 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vasomotor SymptomsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ApexCPG LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112651
- Sponsor's protocol ID
- APX/VMS/CL25216/25
- Status last verified
- Nov 2025
- First submitted
- 2 Aug 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deecher DC, Dorries K. Understanding the pathophysiology of vasomotor symptoms (hot flushes and night sweats) that occur in perimenopause, menopause, and postmenopause life stages. Arch Womens Ment Health. 2007;10(6):247-57. doi: 10.1007/s00737-007-0209-5. Epub 2007 Dec 12.
PubMed 18074100Heger M, Ventskovskiy BM, Borzenko I, Kneis KC, Rettenberger R, Kaszkin-Bettag M, Heger PW. Efficacy and safety of a special extract of Rheum rhaponticum (ERr 731) in perimenopausal women with climacteric complaints: a 12-week randomized, double-blind, placebo-controlled trial. Menopause. 2006 Sep-Oct;13(5):744-59. doi: 10.1097/01.gme.0000240632.08182.e4.
PubMed 16894335Su HI, Freeman EW. Hormone changes associated with the menopausal transition. Minerva Ginecol. 2009 Dec;61(6):483-9.
PubMed 19942836Santoro N, Roeca C, Peters BA, Neal-Perry G. The Menopause Transition: Signs, Symptoms, and Management Options. J Clin Endocrinol Metab. 2021 Jan 1;106(1):1-15. doi: 10.1210/clinem/dgaa764.
PubMed 33095879Santoro N. Perimenopause: From Research to Practice. J Womens Health (Larchmt). 2016 Apr;25(4):332-9. doi: 10.1089/jwh.2015.5556. Epub 2015 Dec 10.
PubMed 26653408
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of CL25216 on Vasomotor Symptoms in Women During Perimenopause: a Randomised, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT07112651
- Acronym / sponsor ID
- APX/VMS/CL25216/25
- Conditions
- Vasomotor Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ApexCPG LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2025 (estimated)
- Primary completion
- 12 Jun 2026 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 8 Aug 2025 (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 is to evaluate the effects of CL25216 on vasomotor symptoms in women during Perimenopause. Enrolled subjects will receive either CL25216 - 250 mg/day or placebo.
Detailed description
The purpose of this study is to evaluate the effects of CL25216 on vasomotor symptoms in women during perimenopause. A total of 80 female aged between40-55 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either CL25216 - 250 mg or placebo arms at 1:1ratio. The subjects will be instructed to take one capsule a day after breakfast for 105 days. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the CL25216 will also include routine laboratory investigations on blood, urine and clinical chemistry at Screening/Randomisation visit and the final visit of the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CL25216 | Experimental | Dietary Supplement: CL25216250 mg to take one capsule a day after breakfast for 105 days |
| Placebo | Other | Dietary Supplement: PlaceboOne capsule a day after breakfast for 105 days |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy overweight women (BMI: 25-29 kg/m2) aged between 40 to 55 years with reports of changes in their menstrual cycle for at least 3 months.
- Participants needed to have a total score of greater than 16 on the Greene Climacteric Scale (GCS), have an intact uterus and ovaries.
- Early Perimenopausal Women according "The Stages of Reproductive Aging Workshop (STRAW) Classification (-2)" irregular periods without skipping menstrual cycles and more than seven days difference in length of consecutive cycles.
- Subjects with serum FSH >20 U/L on 3-5 days of menstrual cycle.
- Subjects with normal pelvic TVS and breast mammogram.
Key exclusion criteria (19 listed)
- History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years, on anti-coagulant or anti-platelet drugs daily for any conditions.
- Subjects who had received hormonal treatment or any other herbal products in the previous 6 months.
- Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
- Subjects diagnosed with ovarian cysts ≥ 4 cm or any underlying pathology in pelvic ultrasonography (USG) performed during screening.
- Chronic or acute life stressors relating to a major life change, experiencing depression and/or receiving medication for such illness or disorders, receiving statins or other drugs known to impact on steroid hormone levels.
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 |
|---|---|---|
| CL25216250mg to take one capsule a day after breakfast for 105 days | Dietary supplement | CL25216 |
| PlaceboOne capsule a day after breakfast for 105 days | Dietary supplement | Placebo |
Primary outcome
Change from baseline to the end of the study period in: Scores of Greene Climacteric Scale (GCS)
Time frame: Day 1, 35, 70, and 105
The Greene Scale is a validated instrument designed to provide a concise assessment of menopause symptoms. It consists of 21 items, each measuring the severity of climacteric symptoms on a scale from 0 (none) to 3 (severe), where 1 indicates mild and 2 indicates moderate symptoms. The total score ranges from 0 to 63, with higher scores reflecting more severe climacteric symptoms.
19 secondary outcomes
Change from baseline to the end of the study period in: GCS sub-scale psychological symptoms
Time frame: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: GCS sub-scale scores: somatic/ physical symptoms
Time frame: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: GCS sub-scale scores: vasomotor symptoms.
Time frame: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Resting Metabolic Rate (RMR)
Time frame: Day 1, and 105
Change from baseline to the end of the study period in: Positive and Negative Affect Schedule (PANAS-X)
Time frame: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Quality of life questionnaire (Short Form -36)
Time frame: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Sexual Function - Female Sexual Function Index (FSFI)
Time frame: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: The Hot Flush Weekly Weighted Score (HFWWS)
Time frame: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Bodyweight
Time frame: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: BMI
Time frame: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Scores of subjective self-assessments on hair quality
Time frame: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Skin wrinkle assessment
Time frame: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Subject's self-assessment of skin Questionnaire
Time frame: Day 1, 35, 70, and 105
Change from baseline to the end of the study period in: Lipids
Time frame: Day 1, and 105
Change from baseline to the end of the study period in: HOMA-IR
Time frame: Day 1, and 105
Change from baseline to the end of the study period in: FSH
Time frame: Day 1, and 105
Change from baseline to the end of the study period in: LH
Time frame: Day 1, and 105
Change from baseline to the end of the study period in: 17 beta-estradiol
Time frame: Day 1, and 105
Change from baseline to the end of the study period in: AMH
Time frame: Day 1, and 105
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 5 Dec 2025.
- Background: PubMed 18074100Deecher DC, Dorries K. Understanding the pathophysiology of vasomotor symptoms (hot flushes and night sweats) that occur in perimenopause, menopause, and postmenopause life stages. Arch Womens Ment Health. 2007;10(6):247-57. doi: 10.1007/s00737-007-0209-5. Epub 2007 Dec 12.
- Background: PubMed 16894335Heger M, Ventskovskiy BM, Borzenko I, Kneis KC, Rettenberger R, Kaszkin-Bettag M, Heger PW. Efficacy and safety of a special extract of Rheum rhaponticum (ERr 731) in perimenopausal women with climacteric complaints: a 12-week randomized, double-blind, placebo-controlled trial. Menopause. 2006 Sep-Oct;13(5):744-59. doi: 10.1097/01.gme.0000240632.08182.e4.
- Background: PubMed 19942836Su HI, Freeman EW. Hormone changes associated with the menopausal transition. Minerva Ginecol. 2009 Dec;61(6):483-9.
- Background: PubMed 33095879Santoro N, Roeca C, Peters BA, Neal-Perry G. The Menopause Transition: Signs, Symptoms, and Management Options. J Clin Endocrinol Metab. 2021 Jan 1;106(1):1-15. doi: 10.1210/clinem/dgaa764.
- Background: PubMed 26653408Santoro N. Perimenopause: From Research to Practice. J Womens Health (Larchmt). 2016 Apr;25(4):332-9. doi: 10.1089/jwh.2015.5556. Epub 2015 Dec 10.
- Individual participant dataSharing planned: No
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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 CL25216 in people with Vasomotor Symptoms, run by ApexCPG LLC at 1 site in India.
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 10 inclusion and 19 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 5 Dec 2025. 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 India. 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. 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 Mr. T.V.N. Rao (+91 8331015069, tvnrao.apex@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to the end of the study period in: Scores of Greene Climacteric Scale (GCS) (time frame: Day 1, 35, 70, and 105). 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 NCT07112651, which also lists 5 linked publications.
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 5 Dec 2025.