| CTRI Number |
CTRI/2020/03/024092 [Registered on: 19/03/2020] Trial Registered Prospectively |
| Last Modified On: |
19/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of AYUSH AGT lotion in Dandruff. |
|
Scientific Title of Study
|
An open label clinical trial to evaluate efficacy and safety of AYUSH AGT in Dandruff (Darunaka). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Savita poshatti Gopod |
| Designation |
Research officer (Ayu) |
| Affiliation |
Regional Ayurveda research institute for skin disorders,v vijayawada |
| Address |
Regional Ayurveda research institute for skin disorders, New Rajeev nagar, Technical section, Room no. 205, Payakapuram, Vijayawada
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
9177777631 |
| Fax |
|
| Email |
savitagopod18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Gopod |
| Designation |
Research officer(Ayu) |
| Affiliation |
Central Council For Research in Ayurvedic Sciences, New Delhi |
| Address |
Regional Ayurveda Research Institute for Skin Disorder
New Rajeev Nagar Payakapuram
Vijayawada 520015
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
9177777631 |
| Fax |
|
| Email |
savitagopod18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSavita Gopod |
| Designation |
Research officer(Ayu) |
| Affiliation |
Central Council For Research in Ayurvedic Sciences, New Delhi |
| Address |
Regional Ayurveda Research Institute for skin disorder
New rajeev nagar payakapuram
Vijayawada 520015
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
9177777631 |
| Fax |
|
| Email |
savitagopod18@gmail.com |
|
|
Source of Monetary or Material Support
|
| central council for research in ayurvedic sciences ministry of ayush govt of india |
|
|
Primary Sponsor
|
| Name |
central council for research in ayurvedic sciences ministry of ayush govt of india |
| Address |
Jawaharlal neharu, bharatiya chikista evam homeopathy anusandhan bhavan, 61-65 institutional area, opp D Block, Janakapuri, New Delhi |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kiran Deshbhratar |
egional Ayurveda Research Institute for Skin Disorders, Ahmedabad (RARISD) |
over bridge, Block A & D, second floor, Bahumali bhavan, Manjushree mill compound, Girdharnagar, Asarwa, Ahmedabad, Gujarat , out patient department
Ahmadabad
GUJARAT |
9890746684
rarisd.amd-ayush@gov.in |
| Dr Raghavendra Naik |
Regional Ayurveda Research Institute for Metabolic Disorders (RARIMD), Bengalur |
Uttarahalli -Manavarthekaval, Karnataka , Outpatient department
Bangalore
KARNATAKA |
8105683022
ayuraghu@gmail.com |
| Dr Savita Gopod |
Regional Ayurveda research institute for skin disorders, vijayawada |
RARISD,New Rajeev nagar vijayawada
Outpatient department
Krishna
ANDHRA PRADESH |
9177777631
savitagopod18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee regional ayurveda research institute for metabolic disorders, Bangalore |
Approved |
| Institutional Ethics committee, Vijayawada |
Approved |
| nstitutional ethics committee, Ahmadabad |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L219||Seborrheic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
AYUsh AGT lotion |
The medicine may be applied on head every alternate day for a period of 30 days. The head may be washed after 1 hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex in the age group 18-50 years
2.Patients diagnosed with mild to moderate
dandruff, assessed by mean total Adherent Scalp
Flaking Score (ASFS) of 8 zones in the scalp.
3.Dandruff restricted to the scalp with itchy, flaky skin without visible inflammation.
4.Patients willing to participate in the study for 45 days.
|
|
| ExclusionCriteria |
| Details |
1.Patients diagnosed with severe dandruff.
Itching, flaking, pruritis and visible inflammation over face, retro-auricular area, and the upper chest.
2.Known C/O psoriasis.
3.Patients with inflammatory or infective scalp conditions
4.Patients with endocrine related diseases such as thyroid diseases which might cause hair fall.
5.Patients with uncontrolled Diabetes Mellitus having HbA1C > 8%.
6.Patients with history of hypersensitivity to hair products
7.Any other condition which the P.I. thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Ayush AGT Lotion in dandruff by means of Adherent Scalp Flaking Score(ASFS). |
15th day and 30th day of study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ï¶Symptomatic improvement in Ayurvedic symptoms of Darunaka (dandruff) such as kesabhumi prapatana(flaking of scalp), Kandu(itching in scalp) and rukshata( dryness of scalp) by using Visual Analogue Scale (VAS).
ï¶ Improvement in Quadrant Area Severity Scale.
Improvement in Dermatology Life Quality Index (DLQI
|
15th day and 30th day |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/04/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a An Open Label
Clinical Trial to Evaluate Clinical Efficacy and Safety of AYUSH AGT lotion in Dandruff
(Darunaka). The medicine may be
applied on head every alternate day for a period of 30 days. The head may be
washed after 1 hr. Study
sample size will be 50 patients for each center. It will be conducted in three
centers in India. Primary Outcome Measures is to assess
the efficacy of Ayush AGT Lotion in dandruff by means of Adherent Scalp
Flaking Score (ASFS). Secondary outcome measures to see
Symptomatic improvement in Ayurvedic symptoms of Darunaka (dandruff)
such as kesabhumi prapatana(flaking of scalp), Kandu(itching in scalp) and
rukshata( dryness of scalp) by using Visual Analogue Scale (VAS), to see the Improvement
in Quadrant Area Severity Scale and improvement in Dermatology Life Quality
Index (DLQI).
|