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Clinical Trial Details (PDF Generation Date :- Sun, 18 Oct 2020 14:12:43 GMT)

CTRI Number CTRI/2015/06/005873 [Registered on: 04/06/2015] - Trial Registered Retrospectively

Last Modified On 02/04/2013
Post Graduate Thesis No
Type of Trial PMS
Type of Study Drug
Study Design Single Arm Trial
Public Title of Study Anastim in management of Hairloss
Scientific Title of ANASTIM study: ANastim (Neoruscine, Tocopherol nicotinate, GP4G and Biotin) Assessment of
Study Safety and Tolerability In Management of Hairloss
Secondary IDs if Any Secondary ID Identifier
Anastim- AHPL / 03/ 2012 , Version final dated Protocol Number
03/04/2012
Details of Principal Details of Principal Investigator
Investigator or overall
Name DrMurugusundaram
Trial Coordinator
(multi-center study) Designation Director
Affiliation Chennai Skin Foundation and Yesudian Research Institute
Address Skin, Hair & Nail Specialist, No. 853/250, Skin, Hair & Nail Clinic,
Thyagaraja Complex, 2nd floor, Next to Breeze Hotel, Poonamallee
High Road, Kilpauk, Chennai
Chennai
TAMIL NADU
600010
India
Phone 044-26613494
Fax
Email [email protected]
Details Contact Details Contact Person (Scientific Query)
Person (Scientific
Name DrManoj Naik
Query)
Designation Chief Manager
Affiliation Abbott Healthcare Pvt Ltd
Address D-Mart Building, Goregaon Mulund Link Road, Mulund (w),Mumbai
Mumbai
MAHARASHTRA
400080
India
Phone 022-39536910
Fax 022-39536665
Email [email protected]
Details Contact Details Contact Person (Public Query)
Person (Public Query)
Name Manoj Prabhu
Designation Manager
Affiliation Abbott Healthcare Pvt Ltd
Address D-Mart Building, Goregaon Mulund Link Road, Mulund (w),Mumbai
Mumbai
MAHARASHTRA
400080
India
Phone 022-39536910

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Fax 022-39536665
Email [email protected]
Source of Monetary or Source of Monetary or Material Support
Material Support
> Abbott Healthcare Pvt Ltd, Mumbai
Primary Sponsor Primary Sponsor Details
Name Abbott Healthcare Pvt Ltd
Address D-Mart Building, Goregaon Mulund Link Road, Mulund (w), Mumbai
Type of Sponsor Pharmaceutical industry-Global
Details of Secondary Name Address
Sponsor
Nil
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
DrAlkaDogra Alka Dogra Clinic 321 Sham singh road, 9815070007
Near Bharat Nagar
Chowk, Ludhiana [email protected]
Ludhiana
PUNJAB
DrRenita Rajan Chennai Skin Hair Nail 124/9, Bharati Colony, 9894488797
Clinic Thirumangalam
Signal,Anna Nagar [email protected]
Chennai
TAMIL NADU
DrNeelima Sharma Hairline Clinic 5AC/321, Bhuvanagari, 9535096530
Banswadi-560043
Bangalore [email protected]
KARNATAKA
DrAmitLuthra Ishira Skin and Child 24-A, Pocket-A, Ashok 9312507117
Clinic Vihar
North [email protected]
DELHI m
DrDBN Murthy Murthy Clinic 8-3-945, Lane OPP JC 2373336
Brothers, Pancom
Business Centre, [email protected]
Ameerpet
Hyderabad
ANDHRA PRADESH
Dr Subha Kesari Nypunya Aesthetic Add- Behind Shanthi 9632150626
Clinic Nursing Home.
Jayanagar 4th block. [email protected]
Bangalore -41
Bangalore
KARNATAKA
DrAmee Reviva Aesthetic #30/A,1ST 9379637234
Centre FLOOR,14TH CROSS,
HSR Layout,Bangalore [email protected]
Bangalore
KARNATAKA
DrKalpana Sarangi Sarangi Clinic 304, Mohini 9820188903
Corner,Annapurna
CHSL,New Link Road, [email protected]
Oshiwara, Andheri
Mumbai

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MAHARASHTRA
DrMurugusundaram Skin Hair and Nail clinic Thyagaraja Complex, 2661394
Next to breeze hotel,
Kilpauk [email protected]
Chennai
TAMIL NADU
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
League Health Approved 25/03/2013 Yes
Independence Ethics
Committee
Regulatory Clearance Status Date
Status from DCGI
Not Applicable No Date Specified
Health Condition / Health Type Condition
Problems Studied
Patients Hair Loss patients
Intervention / Type Name Details
Comparator Agent
Intervention Anastim (Neuroruscin, Anastim to be applied once
Tocopherol nicotinate , GP4G daily three times a week in the
and Biotin) evening 2.5 ml to dry or wet
hair, massage gently for 2
months
Inclusion Criteria Inclusion Criteria
Age From 18.00 Year(s)
Age To 40.00 Year(s)
Gender Both
Details 1.Healthy male and female subjects who are 18 to 40 years of age.
2.Patients with hair loss disorders such as telogen effluvium (as first
line therapy), chronic female pattern hair loss, Androgenetic Alopecia
(Stage I – IV) (as combination with minoxidil)
3.Site involved - scalp

Exclusion Criteria Exclusion Criteria

Details 1.Androgenetic alopecia (Stage V and beyond)
2.Evidence of dermatological disease as revealed by history,
physical examination or laboratory assessment which may interfere
with administration or assessment of study medication
3.Current use of dermatological drugs / preparations which may
interfere with study evaluation
4.Intolerance to any of ingredients of the formulation
5.Current alcohol or drug abuse
6.Subjects viewed by the investigator as not being able to complete
the study.
7.Hair product such as hair dyes, sprays, setting gels and restorers
8.Any procedures for hair enhancement and curling or straightening
techniques
9.Pregnant or breastfeeding women
10.Patient or having participated in a clinical trial in the month before

Method of Generating Not Applicable

Random Sequence
Method of Not Applicable
Concealment
Blinding/Masking Not Applicable
Primary Outcome Outcome Timepoints

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•Improvement in hair growth by clinical digital Baseline & 8 weeks

photography

Secondary Outcome Outcome Timepoints

•Percentage of patients responding to the Baseline & 8 weeks
therapy
•Hair Pull test (or additional Hair Shedding test)
•Adverse event assessment
•Acceptability of the treatment
•Tolerance of the treatment
•Global assessment for efficacy by Investigator
and Patient
•Global assessment for tolerability by
Investigator and Patient

Target Sample Size Total Sample Size=150

Sample Size from India=150
Final Enrollment numbers achieved (Total)=
Final Enrollment numbers achieved (India)=
Phase of Trial Post Marketing Surveillance
Date of First 02/07/2012
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=0
Trial Months=4
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details
Brief Summary To evaluate the efficacy, safety and tolerability of Anastim (Neuroruscin,
Tocopherol nicotinate , GP4G and Biotin) in patients with hair loss.

After satisfying the Inclusion / Exclusion criteria and signing the written informed
consent the patients will be allocated the treatment.

The medical history and symptoms will be recorded in the CRF. All the data will
be recorded in the CRF. At the baseline micro photography or clinical digital
photography assessment and hair pull test (or additional hair shedding test)
assessment will be done.

Qualified subjects will have their global images taken to document hair loss since
the screening visit, the target site area of the scalp will be identified to determine
the baseline hair density.

They will then be prescribed their treatment. Subjects during their visit at Week 8
i.e end of the treatment will be assessed for their improvement in new hair
growth, micro photography or clinical digital photography assessment and hair
pull test (or hair shedding test)

Subject questionnaire assessment will be done at baseline and week 8. Subjects

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during their visit at Week 8 will be assessed for adverse events burning, stinging,
irritation, etc. Additionally, doctor assessment questionnaire will be done at
baseline and week 8.

At the final visit week 8 , global assessment of efficacy and tolerability will be
recorded and will be evaluated by the attending dermatologist and findings will be
noted in the case record form.

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