| CTRI Number |
CTRI/2020/01/023074 [Registered on: 31/01/2020] Trial Registered Prospectively |
| Last Modified On: |
30/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the safety and efficacy of Cynatine HNS (hydrolyzed keratine peptide
capsule 250 mg) |
|
Scientific Title of Study
|
A Randomized, Double-blind, Placebo-controlled, Parallel group, Observational Clinical
Trial to evaluate the safety and efficacy of Cynatine HNS (hydrolyzed keratine peptide
capsule 250 mg) Versus Maltodextrin Oral Capsule on hair and nail parameters. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CYN/CT-OBS/2019 Version No.: 1.1, Dated: 02/07/2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshad Dabhade |
| Designation |
Trial Coordinator |
| Affiliation |
Rajpal Hospital, Navi Mumbai |
| Address |
Department of Clinical Research, Ground Floor, Room number 01, Plot No 80, Sector 8, Koparkhairane Navi Mumbai, 400709, Maharashtra INDIA
Mumbai (Suburban)
MAHARASHTRA
407009
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
mudraclincare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harshad Dabhade |
| Designation |
Trial Coordinator |
| Affiliation |
Rajpal Hospital, Navi Mumbai |
| Address |
Department of Clinical Research, Ground Floor, Room number 01, Plot No 80, Sector 8, Koparkhairane Navi Mumbai, 400709, Maharashtra INDIA
Mumbai (Suburban)
MAHARASHTRA
407009
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
mudraclincare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshad Dabhade |
| Designation |
Trial Coordinator |
| Affiliation |
Rajpal Hospital, Navi Mumbai |
| Address |
Department of Clinical Research, Ground Floor, Room number 01, Plot No 80, Sector 8, Koparkhairane Navi Mumbai, 400709, Maharashtra INDIA
Mumbai (Suburban)
MAHARASHTRA
407009
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
mudraclincare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mudra Clincare, Plot No. 80, Sector - 8, Koparkhairane, Navi Mumbai-400709, Maharashtra, INDIA. |
|
|
Primary Sponsor
|
| Name |
Maxcure Nutravedics Ltd |
| Address |
Plot No- 13, Sector-6A, I.I.E, Sidcul, Ranipur, Haridwar (UK)249403 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mudra Clincare |
Plot No. 80, Sector - 8, Koparkhairane, Navi Mumbai-400709, Maharashtra, INDIA. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priya Waghmare |
Rajpal Hospital |
Department of Medicine, Room number 01, First Floor, Sector 10, near D-mart Koparkhairane
Mumbai (Suburban)
MAHARASHTRA |
8291745386
clinicalsite.rajpal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ashirwad Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cynatine HNS (hydrolyzed keratine peptide capsule 250 mg) |
250 mg Orally twice daily
Duration 14 days |
| Comparator Agent |
Maltodextrin Oral Capsule |
One capsule twice daily
Duration 14 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. All subjects willing to fill and sign ICFs [Informed Consent Forms]
2. Only females having age ≥ 25 to ≤ 65 years.
3. Females having clinical signs of stressed or damaged hairs.
4. Females with an agreement, not to use other possible cosmetic treatments which could interfere with the study.
5. Subject able to follow study procedures.
6. In generally good health.
7. Female, using birth control
8. Subjects who are able and are willing to comply with the protocol
9. Subjects ready to follow-up for entire duration of the study. |
|
| ExclusionCriteria |
| Details |
1. Subjects unwilling to sign on ICF
2. Any dermatological condition of the scalp other than hair loss and /or dandruff.
3. 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.
7. Subject had ever received radiation therapy to the scalp, or had chemotherapy within the past year.
8. Subject had participated in any investigational study within the 30 days prior to trial.
9. 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.
10. Subjects unwilling or unable to comply with the study procedures |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in hair and nail parameters
2. Physician’s and subjects’ Global Assessment |
1. Visit 3,4 and 5
2. Visit 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of participants reporting adverse events
2. Mean change in the vital parameters from baseline to each post randomization visit |
1. by Visit 2,3,4 and 5
2. Visit 1 to 5 |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be conducted after obtaining written informed
consent voluntarily from the subjects. The subjects will undergo screening procedures.
General examination, vital signs will be recorded for each
visit. 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.
|