A Study to Evaluate the Effect of Zandu Hair Growth Ayurvedic Capsule on Hair Growth, Hair Fall Reduction, and Hair Quality in Adults
Scientific Title of Study
A Prospective, Placebo control, Comparative, Clinical Study to Evaluate the Efficacy and Safety of Zandu Hair Growth Ayurvedic Capsule in Promoting Hair Growth, Reducing Hair Fall, and Improving Hair Quality in Adults.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
MR/2024-004 Version No 01 date 15 Mar 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
(1) Medicine Name: Zandu Hair Growth Ayurvedic Capsule, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 710(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: water), Additional Information: one capsule twice daily around same time every day
2
Comparator Arm (Non Ayurveda)
-
Pacebo
Placebo Capsule, Route: Oral, Dosage Form: Capsules, Frequency: bd, Additional Information: one capsule twice daily around same time every day
Inclusion Criteria
Age From
20.00 Year(s)
Age To
55.00 Year(s)
Gender
Male
Details
1.Male subjects aged between 20 to 55 years and female subjects aged between 18 to 45 years.
2.Individuals experiencing hair fall, hair thinning, or complaints of poor hair texture for at least 3 months.
3.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures
ExclusionCriteria
Details
1.Participants with a known allergy or hypersensitivity to any ingredient in the Zandu Hair Growth Ayurvedic Capsule or similar products.
2.Individuals with significant dermatological conditions affecting the scalp, such as psoriasis, eczema, seborrheic dermatitis, or active scalp infections.
3.Participants who have undergone hair treatments such as hair transplants, chemical treatments (dyes, perms, straightening), or the use of hair growth products (e.g., minoxidil, finasteride) within the last 6 months.
4.Pregnant or breastfeeding women.
5.Participants currently taking or having taken hormonal therapies (e.g., corticosteroids, hormonal birth control, testosterone supplements) within the past 3 months.
6.Participants who have undergone major surgery within the last 3 months.
7.Individuals who have received chemotherapy or radiation therapy within the past 12 months.
8.Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator.
9.Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
10.Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
11.Suspected inability or unwillingness to comply with the study procedures.
12.Female subjects of childbearing potential not be willing to use an acceptable method of contraception.
13.Pregnant woman or lactating mother.
Method of Generating Random Sequence
Other
Method of Concealment
Not Applicable
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
Increase in Hair Growth: Measured by hair count and hair length from standardized
scalp areas, before and after 90 days of treatment
90 days
Secondary Outcome
Outcome
TimePoints
Reduction in Hair Fall: Assessed through participant-reported hair shedding (e.g., hair
strands lost during combing or washing), and visual or quantitative assessments at
baseline and after 90 days.
2. Improvement in Hair Texture: Evaluated by participant feedback on parameters such
as smoothness, shine, strength, and general hair health, measured on a Likert scale or
visual analog scale (VAS).
3. Increase in Hair Density: Assessed by dermatological examination or trichoscopy to
measure the thickness and volume of hair in predefined scalp areas, comparing baseline
and end-of-study results.
90 days
Target Sample Size
Total Sample Size="60" Sample Size from India="60" Final Enrollment numbers achieved (Total)= "60" Final Enrollment numbers achieved (India)="60"