| CTRI Number |
CTRI/2021/05/033789 [Registered on: 25/05/2021] Trial Registered Prospectively |
| Last Modified On: |
02/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Anti Dandruff action of Meera anti Dandruff Powder |
|
Scientific Title of Study
|
A Randomized, Single blinded, Placebo controlled Clinical Study to Assess the Efficacy and Safety of MEERA Anti Dandruff powder in patients suffering from dandruff disorders |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Sakthi Balan |
| Designation |
Principal Investigator/Medical Consultant |
| Affiliation |
KI3, CRO |
| Address |
Room no.1, Diabetology OPD, Thirumalai Clinic, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet, PONDICHERRY
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan |
| Designation |
Principal Investigator/Medical Consultant |
| Affiliation |
KI3, CRO |
| Address |
Room no.1, Diabetology OPD, Thirumalai Clinic, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet, PONDICHERRY
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Sakthi Balan |
| Designation |
Principal Investigator/Medical Consultant |
| Affiliation |
KI3, CRO |
| Address |
Room no.1, Diabetology OPD, Thirumalai Clinic, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet, PONDICHERRY
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
|
Source of Monetary or Material Support
|
| CavinKare Private Limited, Cavinville, 12, Cenotaph Rd, Rathna Nagar, Alwarpet, Chennai, Tamil Nadu 600018 |
|
|
Primary Sponsor
|
| Name |
CavinKare Private Limited |
| Address |
Cavinville, 12, Cenotaph Rd, Rathna Nagar, Alwarpet, Chennai, Tamil Nadu 600018 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Kannan |
PM Medical Centre |
Room no:10, Medicine OPD, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Vellore
TAMIL NADU |
7708925866
srkguruvarshan@gmail.com |
| Dr Sakthi Balan |
Thirumalai Speciality Clinic |
Thirumalai Clinic, Room no. 1, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet
Pondicherry
PONDICHERRY |
9443627722
saheerose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ki3 |
Approved |
| PM Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L210||Seborrhea capitis. Ayurveda Condition: DARUNAKAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MEERA anti dandruff powder is a 2 in 1 hair wash powder with small onion and Fenugreek with many natural herbs in it. |
Two sachet of powder to be used for hair wash thrice weekly for 2 weeks |
| Comparator Agent |
Placebo |
Two sachet of placebo powder to be used for hair wash thrice weekly for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female subjects who are 18 to 45 years of age.
2. Subjectssuffering from Dandruff of scalp
3. Subjects who are committed not to use medicated/non medicated shampoos/soaps (including soaps containing antibacterial/antifungal agents) or any other antidandruff treatment/hair products (including prescription and non-prescription medications such as hair oil, conditioners) for the entire duration of the study.
4. Subject usually using a shampoo 3 times a week and accepting to follow this rate during the whole study period.
5. Subjects not have participated in any other clinical trial during the past 3 months.
|
|
| ExclusionCriteria |
| Details |
1. Scalp Psoriasis.
2. Subjects who underwent any type of hair procedures within the past 2 weeks or during the study.
3. Subjects with immediate life threatening diseases such as pre-existing cardiovascular, liver or neoplastic disease.
4. Subjects undergoing treatment for immune-compromised conditions/psychiatric illness.
5. Subjects with any other co- morbid conditions like Diabetes that can affect the study outcome.
6. Pregnant or lactating women.
7. Hypersensitivity to any of the components of the test formulation.
8. The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Total Dandruff Severity Score (TDSS)
2. Changes in the intensity of hair fall over 4 weeks from baseline to final treatment visit using Visual Analogue Scale (VAS)
3. Global improvement (self-assessment scoring& Photographs) by the subject.
4. Pull test – to evaluate the severity of hair shedding.
|
Week 1, 2, 3 and 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor for any adverse events during the study period and assess quality of life |
Week 1, 2, 3 and 4 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/05/2021 |
| Date of Study Completion (India) |
01/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The
subjects who fulfilled the inclusion and exclusion criteria will be enrolled in
the study. The selected subjects will be asked to self-administer the MEERA anti dandruff hair wash
powder as per the dosing instructions. The evaluation visits are as follows, Visit 1 (Day 1)- Screening and Baseline evaluation
day before wash in period, and starting of Placebo), screening, obtaining ICF
and questionnaire.
Visit 2- (Day 8)-1st week-(After 1 week
of Placebo usage)- End of Placebo Study & Active samples Placement. Dermatologist
assessment and sensory feedback will be collected from each volunteer
Visit 3-(Day 22)- 3rd week -(End of Active sample)- (After 2
weeks of Active sample usage)-
Placement of Placebo- Recurrence phase. Dermatologist assessment and
sensory feedback will be collected from each volunteer
Visit 4-(Day 30) 4th week- (After 1 week
of placebo). End of Recurrence phase -Study closure- Dermatologist assessment
and sensory feedback will be collected from each volunteer |