To evaluate the safety and efficacy of Cynatine HNS (hydrolyzed keratine peptidecapsule 250 mg)

Suspended

• Conditions: Administration,

• Registration Number: CTRI/2020/01/023074
• Lead Sponsor: Maxcure Nutravedics Ltd

Brief Summary

The study will be conducted after obtaining written informedconsent voluntarily from the subjects. The subjects will undergo screening procedures.

General examination, vital signs will be recorded for eachvisit. The aim of this study is to evaluate and compare the safety and efficacy of Cynatine HNS (hydrolyzed keratine peptide capsule 250 mg) versus Maltodextrin Oral Capsule on hair and nail parameters in a randomized, double-blind, Placebo-controlled, Parallel group, Observational clinical trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-02
• Last Update Posted: 2021-05-30

Recruitment & Eligibility

• Status: Suspended
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• All subjects willing to fill and sign ICFs [Informed Consent Forms] 2.
• Only females having age ≥ 25 to ≤ 65 years.
• Females having clinical signs of stressed or damaged hairs.
• Females with an agreement, not to use other possible cosmetic treatments which could interfere with the study.
• Subject able to follow study procedures.
• In generally good health.
• Female, using birth control 8.
• Subjects ready to follow-up for entire duration of the study.

Exclusion Criteria

• Subjects unwilling to sign on ICF 2.
• Any dermatological condition of the scalp other than hair loss and /or dandruff.
• Any prior hair growth procedures (e.g., hair transplant or laser) 4.
• History of alcohol or drug addiction 5.
• History of skin allergy 6.
• Any active skin infection in the scalp area or scarring in the target area.
• Subject had ever received radiation therapy to the scalp, or had chemotherapy within the past year.
• Subject had participated in any investigational study within the 30 days prior to trial.
• A history or the presence of any serious and/or chronic medical condition(s) including psychiatric illnesses] which, in the opinion of the investigator, may cause harm to the individual and/or compromise/confound the study results.
• Subjects unwilling or unable to comply with the study procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in hair and nail parameters	1. Visit 3,4 and 5 | 2. Visit 5
2. Physician’s and subjects’ Global Assessment	1. Visit 3,4 and 5 | 2. Visit 5

Secondary Outcome Measures

Name	Time	Method
1. Number of participants reporting adverse events	2. Mean change in the vital parameters from baseline to each post randomization visit

Trial Locations

Locations (1)

Rajpal Hospital; 🇮🇳 (Suburban), MAHARASHTRA, India

Rajpal Hospital

🇮🇳(Suburban), MAHARASHTRA, India

Dr Priya Waghmare

Principal investigator

8291745386

clinicalsite.rajpal@gmail.com