Hair Fall and Pre-mature GrayingNCT06552039

Proof-of-Science, Prospective, Interventional, Three-arm, Double-Blind, Randomized, Safety and Efficacy Real World Evidence Study.

A study testing Polyherbal Hair Oil, Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair Serum and Minoxidil Hair Serum in people with Hair Fall and Pre-mature Graying, run by NovoBliss Research Pvt Ltd at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is proof-of-science, prospective, interventional, three-arm, double-blind, randomized, safety and efficacy real world evidence study of herbal and non herbal formulations in healthy human subjects having complaint of hair fall and pre-mature graying. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Hair Fall and Pre-mature Graying
What is being tested?: Polyherbal Hair Oil, Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair Serum and Minoxidil Hair Serum
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 99 participants
Where: 1 siteIndia
Study dates: 26 Dec 2024to 28 Jun 2025
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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age: 18 to 55 years and above (both inclusive) at the time of consent.
Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
Females of childbearing potential must have a self-reported negative urine pregnancy.
Subject is in good general health as determined by the Investigator on the basis of medical history.
Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
Subject having AGA and premature Gray hair at a time of screening.

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Subject having premature gray hair at a time of screening.
Subject with pro-claimed nonpathological thinning of hair.
Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will beconsidered as non-childbearing potential if they are surgically sterile, have been post menopausal for at least 1 year or have had a tubal ligation.
Subjects are willing to give written informed consent and are willing to follow the study procedure.
Subjects who commit not to use any other medicated/ prescription shampoos/hair care products (containing Minoxidil), any other hair growth products or hair colour or dye, other than the test products for the entire duration of the study.
Willing to use test products throughout the study period.
Subject is willing and able to follow and allow study staff to performed study test methods.
Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
Subject must be able to understand and provide written informed consent to participate in the study

Who cannot join

Subject have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
Subject have history of any dermatological condition of the scalp other than hair loss and dandruff.
Subject have history of any prior hair growth procedures (e.g. hair transplant or laser).
Subject who had taken topical treatment of hair loss for at least 4 weeks.
Subject who had taken any systemic treatment for at least 3 months.
History of alcohol or drug addiction.

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Subject having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study.
Pregnant or breast feeding or planning to become pregnant during the study period.
History of chronic illness which may influence the cutaneous state.
Subject have participated any clinical research study related to hair care products.
Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.

Trial locations and contacts

1 site in 1 country.

India1 site

NovoBliss Research Pvt Ltd
Ahmedabad, Gujarat, 382481

Other trials in India

About this study

Official title: Scientific Evaluation of the Safety and Efficacy of Herbal and Non Herbal Formulations in Mitigating Hair Fall, Promoting Hair Growth, and Preventing Premature Hair Graying.

Read the detailed description

Considering the clinical safety, efficacy study a sufficient number 99 subjects (33 subject/arm) will be enrolled to 90 subjects (30 subject/arm) completed the study. In each arm, fifteen (15) participants per group will be recruited, with one group consisting of individuals experiencing mild to moderate Androgenetic Alopecia (AGA) class 1, 2, 3, while the other group will comprise fifteen (15) healthy subjects with symptoms of hair loss and premature graying. The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. The adult female/male subjects will be instructed to visit the facility as per the below visits.

Visit 01 (Day -04): Screening, Tattoo creation, Hair Growth Rate measurement
Visit 02 (Day 01): Enrolment, Hair Growth Rate measurement, All evaluations
Visit 03 (Day 45 (±2 days)): Treatment Phase
Visit 04 (Day 87 (±2 days)): Treatment Phase, Tattoo creation, Hair Growth Rate measurement Visit 05 (Day 90 (3 days from visit 04): Hair Growth Rate measurement, All evaluations
Visit 06: (Day 120 (±2 days)): End of Treatment Phase, All evaluations

Conditions: Hair Fall and Pre-mature Graying
Being tested: Polyherbal Hair Oil, Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair Serum, Minoxidil Hair Serum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Polyherbal Hair OilOther
Apply oil with the help of fingertips on your scalp and massage it gently enabling it to penetrate into the roots (follicle) of your hair. Don't apply with your palms and never rub it vigorously as it may uproot weak hair. Let the oil gradually seep into follicle of your hair \& nourish them for the whole night. The oil may be removed in the morning by washing of hair with Ayurvedic Shampoo. Dosage form: liquid frequency: Three times a week Route of Administration: Topical
Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair SerumOther
First, apply the herbal hair oil generously to your scalp and hair, ensuring thorough coverage. Gently massage it in with your fingertips to promote circulation and absorption. After the oil application, follow the instructions provided for the application of the minoxidil hair serum. Apply the serum to the areas of your scalp where you desire hair growth, using the dropper provided or as directed. Massage it gently into your scalp to ensure even distribution and absorption. Leave the serum on without rinsing.
Dosage form: liquid Frequency : For Minoxidil - Daily Night Application For Herbal Hair Oil- Thrice a week.
Route of Administration: Topical
Minoxidil Hair SerumOther
Apply the amount prescribed to the area of the scalp being treated, beginning in the center of the area. Dosage form: liquid Frequency : Daily night Application of Minoxidil Route of Administration: Topical

Study groups in NCT06552039
Study group	Role	What they receive
Polyherbal Hair Oil	Experimental	Apply oil with the help of fingertips on your scalp and massage it gently enabling it to penetrate into the roots (follicle) of your hair. Don't apply with your palms and never rub it vigorously as it may uproot weak hair. Let the oil gradually seep into follicle of your hair \& nourish them for the whole night. The oil may be removed in the morning by washing of hair with Ayurvedic Shampoo. Dosage form: Liquid Frequency: Three times a week Route of Administration: Topical Receives: Other: Polyherbal Hair Oil
Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair Serum	Active comparator	First, apply the herbal hair oil generously to your scalp and hair, ensuring thorough coverage. Gently massage it in with your fingertips to promote circulation and absorption. After the oil application, follow the instructions provided for the application of the minoxidil hair serum. Apply the serum to the areas of your scalp where you desire hair growth, using the dropper provided or as directed. Massage it gently into your scalp to ensure even distribution and absorption. Leave the serum on without rinsing Frequency: For Minoxidil - Daily Night Application For Herbal Hair Oil- Thrice a week Route of Administration: Topical Receives: Other: Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair Serum
Minoxidil Hair Serum	Active comparator	Apply the amount prescribed to the area of the scalp being treated, beginning in the center of the area. Frequency: Daily Night Application of Minoxidil Route of Administration: Topical Receives: Other: Minoxidil Hair Serum

What is being measured

The primary outcome is the main question the study is designed to answer.

change in hair thickness by using CASLite Nova
To assess the effectiveness of the test products in terms of change in hair thickness by using CASLite Nova.
Measured: Baseline before usage of test product on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120
change in hair density by using CASLite Nova
To assess the effectiveness of the test products in terms of hair density by using CASLite Nova.
Measured: Baseline before usage of test product on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120
change in hair growth rate by using CASLite Nova
To assess the effectiveness of the test products in terms of change in hair growth rate by using CASLite Nova
Measured: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120 .
change in hair strength by using hair pull test.
To assess the effectiveness of the test products in terms of change in hair strength by using hair pull test
Measured: Baseline before usage of the test products (04 days before Day 01) and after usage of the test on Day 45, Day 90 and Day 120
change in hair fall by using 60 second hair combing test.
To assess the effectiveness of the test products in terms of change in hair fall by using 60 second hair combing test.
Measured: Baseline before usage of the test products (04 days before Day 01) and after usage of the test on Day 45, Day 90 and Day 120.
change in scalp skin hydration by using Corneometer CM 825
To assess the effectiveness of the test products in terms of change in scalp skin hydration
Measured: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120
change in Anagen: Telogen (A: T) Ratio by using Hair Pluck Test by dermatologist.
To assess the effectiveness of the test products in terms of change in Anagen: Telogen (A: T) Ratio
Measured: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 120
change in ASFS by using ASFS scoring scale.
To assess the effectiveness of the test products in terms of change in ASFS where 0-10 scale (0 means no flakes and 10 means heavy flaking)
Measured: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45 (+2 days), Day 90 (3 days from the visit 04) and Day 120 (+2 days)
change in GSS score by using CASLite Nova
To assess the effectiveness of the test products in terms of change in GSS score
Measured: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 120 (+2 days)

Secondary outcomes (8)

change in general appearance of hair
To assess the effectiveness of the test products in terms of change in general appearance of hair where categorical variable indicated as poor, average and good scale
Measured: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120.
change in general appearance of scalp.
To assess the effectiveness of the test products in terms of change in general appearance of scalp where categorical variable indicated none, mild, moderate and excessive
Measured: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120.
change in digital photographs of the head crown Nikon digital camera D3300
To assess the effectiveness of the test products in terms of change in digital photographs of the head crown
Measured: Before usage of the test products on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120.
change in products perception questionnaire by using 5-point Likert scale
To evaluate the effectiveness of the test products in terms of change in products perception questionnaire
Measured: Before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120
sensorial evaluation on the hair tress by 6 expert evaluation.
To assess the effectiveness of the test products in terms of sensorial evaluation on the hair tress by 6 expert evaluation
Measured: Baseline and post application of the test products on Day 1 at T 60 minutes
change in hair shine using glossymeter GL 200
To assess the effectiveness of the test products in terms of change in hair shine using glossymeter GL 200
Measured: Baseline and post application of the test products on Day 1 at T 60 minutes
change in damage repair of the hair by using SEM analysis
To assess the effectiveness of the test products in terms of change in damage repair of the hair by using SEM analysis
Measured: Baseline on Day 1 and post application of the test products at 120 Days
change in lipid deposition of the hair by using XRF method
To assess the effectiveness of the test products in terms of change in lipid deposition of the hair by using XRF method
Measured: Baseline on Day 1 and post application of the test products at 120 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Dec 202428 Jun 2025

First posted13 Aug 2024
Study start26 Dec 2024
Primary completion28 Jun 2025
Study completion28 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hair Fall and Pre-mature GrayingStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Proof-of-Science, Prospective, Interventional, Three-arm, Double-Blind, Randomized, Safety and Efficacy
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06552039
Sponsor's protocol ID: NB230043-NB
Status last verified: Aug 2026
First submitted: 30 Jul 2024
Last updated: 6 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Scientific Evaluation of the Safety and Efficacy of Herbal and Non Herbal Formulations in Mitigating Hair Fall, Promoting Hair Growth, and Preventing Premature Hair Graying.
ClinicalTrials.gov ID: NCT06552039
Acronym / sponsor ID: NB230043-NB
Conditions: Hair Fall and Pre-mature Graying
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: NovoBliss Research Pvt LtdUniversity, hospital or other
Study start: 26 Dec 2024 (actual)
Primary completion: 28 Jun 2025 (actual)
Study completion: 28 Jun 2025 (actual)
First posted: 13 Aug 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.

Detailed description

Visit 01 (Day -04): Screening, Tattoo creation, Hair Growth Rate measurement
Visit 02 (Day 01): Enrolment, Hair Growth Rate measurement, All evaluations
Visit 03 (Day 45 (±2 days)): Treatment Phase
Visit 04 (Day 87 (±2 days)): Treatment Phase, Tattoo creation, Hair Growth Rate measurement Visit 05 (Day 90 (3 days from visit 04): Hair Growth Rate measurement, All evaluations
Visit 06: (Day 120 (±2 days)): End of Treatment Phase, All evaluations

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: Proof-of-Science, Prospective, Interventional, Three-arm, Double-Blind, Randomized, Safety and Efficacy

Arm	Type	Receives
Polyherbal Hair Oil	Experimental	Other: Polyherbal Hair OilApply oil with the help of fingertips on your scalp and massage it gently enabling it to penetrate into the roots (follicle) of your hair. Don't apply with your palms and never rub it vigorously as it may uproot weak hair. Let the oil gradually seep into follicle of your hair \& nourish them for the whole night. The oil may be removed in the morning by washing of hair with Ayurvedic Shampoo. Dosage form: Liquid Frequency: Three times a week Route of Administration: Topical
Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair Serum	Active comparator	Other: Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair SerumFirst, apply the herbal hair oil generously to your scalp and hair, ensuring thorough coverage. Gently massage it in with your fingertips to promote circulation and absorption. After the oil application, follow the instructions provided for the application of the minoxidil hair serum. Apply the serum to the areas of your scalp where you desire hair growth, using the dropper provided or as directed. Massage it gently into your scalp to ensure even distribution and absorption. Leave the serum on without rinsing Frequency: For Minoxidil - Daily Night Application For Herbal Hair Oil- Thrice a week Route of Administration: Topical
Minoxidil Hair Serum	Active comparator	Other: Minoxidil Hair SerumApply the amount prescribed to the area of the scalp being treated, beginning in the center of the area. Frequency: Daily Night Application of Minoxidil Route of Administration: Topical

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (16 listed)

Age: 18 to 55 years and above (both inclusive) at the time of consent.
Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
Females of childbearing potential must have a self-reported negative urine pregnancy.
Subject is in good general health as determined by the Investigator on the basis of medical history.
Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.

Key exclusion criteria (12 listed)

Subject have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
Subject have history of any dermatological condition of the scalp other than hair loss and dandruff.
Subject have history of any prior hair growth procedures (e.g. hair transplant or laser).
Subject who had taken topical treatment of hair loss for at least 4 weeks.
Subject who had taken any systemic treatment for at least 3 months.

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
Polyherbal Hair OilApply oil with the help of fingertips on your scalp and massage it gently enabling it to penetrate into the roots (follicle) of your hair. Don't apply with your palms and never rub it vigorously as it may uproot weak hair. Let the oil gradually seep into follicle of your hair \& nourish them for the whole night. The oil may be removed in the morning by washing of hair with Ayurvedic Shampoo. Dosage form: liquid frequency: Three times a week Route of Administration: Topical	Other	Polyherbal Hair Oil
Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair SerumFirst, apply the herbal hair oil generously to your scalp and hair, ensuring thorough coverage. Gently massage it in with your fingertips to promote circulation and absorption. After the oil application, follow the instructions provided for the application of the minoxidil hair serum. Apply the serum to the areas of your scalp where you desire hair growth, using the dropper provided or as directed. Massage it gently into your scalp to ensure even distribution and absorption. Leave the serum on without rinsing. Dosage form: liquid Frequency : For Minoxidil - Daily Night Application For Herbal Hair Oil- Thrice a week. Route of Administration: Topical	Other	Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair Serum
Minoxidil Hair SerumApply the amount prescribed to the area of the scalp being treated, beginning in the center of the area. Dosage form: liquid Frequency : Daily night Application of Minoxidil Route of Administration: Topical	Other	Minoxidil Hair Serum

Primary outcome

change in hair thickness by using CASLite Nova
Time frame: Baseline before usage of test product on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120
To assess the effectiveness of the test products in terms of change in hair thickness by using CASLite Nova.
change in hair density by using CASLite Nova
Time frame: Baseline before usage of test product on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120
To assess the effectiveness of the test products in terms of hair density by using CASLite Nova.
change in hair growth rate by using CASLite Nova
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120 .
To assess the effectiveness of the test products in terms of change in hair growth rate by using CASLite Nova
change in hair strength by using hair pull test.
Time frame: Baseline before usage of the test products (04 days before Day 01) and after usage of the test on Day 45, Day 90 and Day 120
To assess the effectiveness of the test products in terms of change in hair strength by using hair pull test
change in hair fall by using 60 second hair combing test.
Time frame: Baseline before usage of the test products (04 days before Day 01) and after usage of the test on Day 45, Day 90 and Day 120.
To assess the effectiveness of the test products in terms of change in hair fall by using 60 second hair combing test.
change in scalp skin hydration by using Corneometer CM 825
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120
To assess the effectiveness of the test products in terms of change in scalp skin hydration
change in Anagen: Telogen (A: T) Ratio by using Hair Pluck Test by dermatologist.
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 120
To assess the effectiveness of the test products in terms of change in Anagen: Telogen (A: T) Ratio
change in ASFS by using ASFS scoring scale.
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45 (+2 days), Day 90 (3 days from the visit 04) and Day 120 (+2 days)
To assess the effectiveness of the test products in terms of change in ASFS where 0-10 scale (0 means no flakes and 10 means heavy flaking)
change in GSS score by using CASLite Nova
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 120 (+2 days)
To assess the effectiveness of the test products in terms of change in GSS score

8 secondary outcomes

change in general appearance of hair
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120.
change in general appearance of scalp.
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120.
change in digital photographs of the head crown Nikon digital camera D3300
Time frame: Before usage of the test products on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120.
change in products perception questionnaire by using 5-point Likert scale
Time frame: Before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120
sensorial evaluation on the hair tress by 6 expert evaluation.
Time frame: Baseline and post application of the test products on Day 1 at T 60 minutes
change in hair shine using glossymeter GL 200
Time frame: Baseline and post application of the test products on Day 1 at T 60 minutes
change in damage repair of the hair by using SEM analysis
Time frame: Baseline on Day 1 and post application of the test products at 120 Days
change in lipid deposition of the hair by using XRF method
Time frame: Baseline on Day 1 and post application of the test products at 120 Days

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 6 Aug 2026.
Individual participant dataSharing planned: No

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.

Dr. Nayan K Patel principal investigator

NovoBliss Research Pvt Ltd

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 inclusion and 12 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 6 Aug 2026. 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?

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?

change in hair thickness by using CASLite Nova (time frame: Baseline before usage of test product on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120). The study lists 9 primary outcomes in all. 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 NCT06552039.

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 6 Aug 2026.