| CTRI Number |
CTRI/2023/05/052349 [Registered on: 08/05/2023] Trial Registered Prospectively |
| Last Modified On: |
28/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Ayurvedic Herbal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation of Khasa beeja tailam external application (Seed oil of Papaver somniferum Linn.) in the cases suffering with Dandruff. |
|
Scientific Title of Study
|
A Clinical study to evaluate the efficacy of Khasa beeja tailam (Seed oil of Papaver somniferum) in Darunaka Vyadhi. |
| Trial Acronym |
A Clinical study to evaluate the efficacy of khasa beeja tailam (Seed oil of Papaver somniferum) in Darunaka Vyadhi |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sridhar Anishetty |
| Designation |
Associate Professor |
| Affiliation |
Anantha Laxmi Govt.Ayurvedic College |
| Address |
Department of Dravyaguna (Indian Materia Medica & Pharmacology),
Labour colony, Laxmipuram,
Warangal - Telangana - 506013
Warangal
TELANGANA
506013
India |
| Phone |
9247716400 |
| Fax |
|
| Email |
drshridhar3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sridhar Anishetty |
| Designation |
Associate Professor |
| Affiliation |
Anantha Laxmi Govt.Ayurvedic College |
| Address |
Department of Dravyaguna (Indian materia medica & pharmacology), Labour colony, Laxmipuram,
Warangal - Telangana - 506013
Warangal
TELANGANA
506013
India |
| Phone |
9247716400 |
| Fax |
|
| Email |
drshridhar3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Metuku Shantiswaroop |
| Designation |
Student |
| Affiliation |
Anantha Laxmi Govt.Ayurvedic College |
| Address |
Room no.8, Department of Dravyaguna, A.L.Govt.Ayurvedic College, Warangal
-
Warangal
TELANGANA
506013
India |
| Phone |
9247716400 |
| Fax |
|
| Email |
metukushanthiswaroopsp@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Central council for Research in Ayurveda Sciences |
| Address |
D-Block, Janakpuri, Delhi |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sridhar Anishetty |
Govt. Ayurvedic Teaching Hospital, attached to A.L.Govt.Ayurvedic College, Warangal |
Room no.18, Department of Swasthya Rakshana, Govt.Ayurvedic Teaching Hospital, Opposite Warangal Bus stand, Warangal, Telangana - 506002
Warangal
TELANGANA |
9247716400
drshridhar3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, A.L.Govt.Ayurvedic College, Warangal |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Khasa beeja or Ahiphena Beeja, Reference: Samhita and Sharanga Samhita, Route: Topical, Dosage Form: Taila, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: Since this oil used externally, quantity sufficient will be used |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects in General good health of either sex. (Subjects without other specific health
complaints.)
2. Subjects within the age group of 18-55 years.
3. Subjects willing to give a written informed consent and willing to abide by and
comply with the study protocol.
4. Subject exhibiting a slight to moderate dandruff or Seborrheic dermatitis of scalp on
the total adherent and non adherent score after clinical examination, on Day 0.
5. Subject having stopped any possible antidandruff treatment at least 2 weeks prior to
Day 0.
|
|
| ExclusionCriteria |
| Details |
1. Associated with other dermatological conditions such as psoriasis etc.
Other Systemic illness.
2. Pregnant, lactating mothers, menopausal women.
3. Any Immuno-compromised patients and uncontrolled Diabetes
4. Systemic treatment with corticosteroids, antibiotics, immune-suppressants etc, or any
modern treatment within 3 months before of this trial.
5. Subjects who have undergone hair growth treatment within 3 months before screening
into the study. Subjects, who have history of alcoholism, smoking, crash dieting and/or
psychiatric disorder including trichotillomania. Subjects who have had hair
transplantation, who have taken pharmaceutical product which cause hirsutism(ex.phenytoin) and finasteride for androgenic alopecia, under medical treatment for
hair problems.
6. A known history or present condition of allergic response/hypersensitivity to any
cosmetic ingredients and pharmaceutical products.
7. Subjects on oral medications, undergoing any chemical hair salon treatmentstraightening / perming / colour / henna which will compromise the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the absence or no visibility of dandruff flakes in comparison to the
baseline.
2.3.2. To determine the percentage reduction in dandruff level in comparison to
baseline. |
0 day 1 week 2 weeks 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the drug acceptance, safety & tolerance |
0 day 1 week 2 weeks 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/05/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/05/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drshridhar3@gmail.com].
- For how long will this data be available start date provided 16-04-2023 and end date provided 15-04-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
‘Darunaka’ is mentioned as a dreadful disease of scalp, where-in skin of scalp is
cracked, dried along with itching due to vitiation of Vata and Kapha doshas, under ‘Kshudra
Rogas’ by Acharya Sushruta and Sharangadhara. Darunaka Vyadhi can be correlated with
the modern nomenclature of diseases as ‘Dandruff & Seborrheic Dermatitis of scalp according
to the International Classification of Diseases (ICD 10 & 11).The major difference between
‘Dandruff’ and Seborrheic Dermatitis (SD) is the area of skin being affected in both the
diseases. Dandruff is limited to the scalp skin and wherein Seborrheic Dermatitis can spread
over the scalp and as well as other Seborrheic areas of the body. Dandruff involves flaking of
skin, itching without any visible inflammation. SD involves flaking or scaling of skin,
itching, inflammation and prutitus.Dandruff is the most exploited scalp disease and is
having very high incidence as much as 50% amongst urban population and it is rapidly
increasing in rural population also. External usage of Ahiphena (Khakhasa) beeja (seeds of
Papaver somniferum Linn.) in Darunaka Vyadhi has been mentioned by Acharya
Sarangadhara. Ahiphena (poppy) seed is an widely used spice and an edible ingredient in
maximum families across India for taste and normal poppy seeds are generally regarded as
safe for internal consumption. Seed
oil contains 70%-73% of linoliec acid, 13%-15% oleic acid, 10%-12.5% palmitic acid, 1%-
2% stearic acid, 0.2%-0.7% linolenic acid and less percentage of tocopherols and having
different pharmacological activities including topical applications. A pilot study is planned to evaluate the efficacy of the seed oil in dandruff. |