CTRI Number |
CTRI/2023/07/055147 [Registered on: 12/07/2023] Trial Registered Prospectively |
Last Modified On: |
23/05/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Effect of Bhringarajaadi Taila and Gunjaadi Taila in Dandruff. |
Scientific Title of Study
|
A Randomized comparative clinical study of Bhringarajaadi Taila and Gunjaadi Taila as external application in the management of Darunaka with special reference to dandruff. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Mital G Rabadiya |
Designation |
PG Scholar |
Affiliation |
National Institute of Ayurveda, jaipur |
Address |
Department of Dravaguna Vigyana, National institute of Ayurveda, Deemed to be University(De-novo) Jorawar singh gate, Amer road, Jaipur Department of Dravaguna Vigyana, National institute of Ayurveda, Deemed to be University(De-novo) Jaipur Jaipur RAJASTHAN 302002 India |
Phone |
7046226624 |
Fax |
|
Email |
mitalrabadiya15@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Tarun Sharma |
Designation |
Assistant Professor |
Affiliation |
National Institute of Ayurveda, jaipur |
Address |
Department of Dravaguna Vigyana, National institute of Ayurveda, Deemed to be University(De-novo) Jorawar singh gate, Amer road, Jaipur Department of Dravaguna Vigyana, National institute of Ayurveda, Deemed to be University(De-novo) Jaipur Jaipur RAJASTHAN 302002 India |
Phone |
9887701733 |
Fax |
|
Email |
tarunsharma1286@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mital G Rabadiya |
Designation |
PG Scholar |
Affiliation |
National Institute of Ayurveda, Jaipur |
Address |
Department of Dravaguna Vigyana, National institute of Ayurveda, Deemed to be University(De-novo) Jorawar singh gate, Amer road, Jaipur Department of Dravaguna Vigyana, National institute of Ayurveda, Deemed to be University(De-novo) Jaipur Jaipur RAJASTHAN 302002 India |
Phone |
7046226624 |
Fax |
|
Email |
mitalrabadiya15@gmail.com |
|
Source of Monetary or Material Support
|
National Institute of Ayurveda, jaipur, Rajasthan |
|
Primary Sponsor
|
Name |
National Institute of Ayurveda department Jaipur, Rajasthan |
Address |
National Institute of Ayurveda department Jaipur, Rajasthan |
Type of Sponsor |
Research institution and hospital |
|
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 Mital G Rabadiya |
National Institute Of Ayurveda |
Department of Dravaguna Vigyana, Jaipur RAJASTHAN |
7046226624
mitalrabadiya15@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics comittee of Ayurveda deemed to be university |
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: Gunjaadi Taila, Reference: Yogaratnakara/ Kshudraroga/ 107, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bhringarajaadi Taila, Reference: Yogaratnkara/ Kshudraroga/ 106, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1 Patients of irrespective gender & socio-economic status.
2 Patients between age group of 18-60 years.
3 Patients with symptoms of Darunaka (Dandruff).
4 Known cases of Darunaka (Dandruff) who are willing to participate to study.
|
|
ExclusionCriteria |
Details |
1 Patients with clinically significant systematic disease eg. Immunological deficiency, AIDS,
current malignancies, uncontrolled diabetes mellitus etc.
2 Other scalp disorders like Psoriasis, Tinea capitis etc.
3 Pregnant and lactating woman
4 Systemic treatment with corticosteroids, antibiotics, immune suppressants etc, or topical
treatments applied to the scalp within 7 days before inclusion in the study and that could
interfere with the results of the study like ketoconazole, antidandruff shampoo etc.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
relief in Darunaka(Dandruff) |
6 Weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Relief in itching
Control in hair fall
|
6 Weeks |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
16/08/2023 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
There
is nothing like healthy hair to make an individual feel confident and
beautiful. Unhealthy hair is always a reason of concern not just for females
but also for males. Damaged hair and scalp are always frustrating factor for
youth. Hair is associated with youthfulness and beauty in women and muscularity
in men; so, it is no surprise that hair loss can make any men and women feel
self-conscious. Pollution. unhygienic conditions and many more factors can
cause hair problem.
Darunaka is classified as one among kapalagataroga by
Acharya Vagbhatta & Sharangdhara and one among kshudraroga
by Acharya Sushruta & others. Darunaka is characterized by kandu(itching),
keshbhoomiprapatyate(scaling of the scalp), rukshata (dryness and
roughness of scalp) etc and all these symptoms are due to vitiation of Kapha
and Vata doshas[1].
दारà¥à¤£à¤¾à¤•णà¥à¤¡à¥à¤°à¤¾à¤°à¥‚कà¥à¤·à¤¾à¤•ेशà¤à¥‚मिःपà¥à¤°à¤ªà¤¾à¤Ÿà¥à¤¯à¤¤à¥‡à¥¥
कफवातपà¥à¤°à¤•ोपेणविदà¥à¤¯à¤¾à¤¦à¥à¤¦à¤¾à¤°à¥à¤£à¤•ंतà¥à¤¤à¤®à¥à¥¥ [सà¥à¥¦à¤¨à¤¿à¥¦à¥§à¥©/३४]
Darunaka can be correlated to dandruff in contemporary
science. Dandruff is a common disorder affecting half of the population at the
pre pubertal age and of any gender and ethnicity.[2] Dandruff is
affecting the scalp and can be an embarrassing condition. Dandruff is
restricted to the scalp and involves itchy flaking skin without visible
inflammation. Seborrheic dermatitis affects the scalp as well as face, retro-
auricular area and the upper chest, causing flaking, scaling, inflammation and
pruritis and can have marked erythema.[3]
The
word dandruff (dandruff, dandriffe) is of Anglo-Saxon origin, a combination of
‘tan’ meaning ‘tetter’ and ‘drof’ meaning ‘dirty’. Dandruff affects aesthetic
value and often causes itching. It has been well established that keratinocytes
play a key role in the expression and generation of immunological reactions
during dandruff formation.[4]
There
are several microbial and nonmicrobial causes of dandruff like over shampooing,
frequent combing, dust, dirt, dry skin, Seborrheic dermatitis sensitivity to
hair care products or yeast. Among the several etiopathology pathway’s role of
lipophilic yeast belongs to genus Malassezia was widely accepted. Seven species
of Malassezia (i.e., M. globose, M. restricta, M. obtuse, M. sloofiae,
M.sympodialis, M.furfur and M. pachydermatis) have been recognized in dandruff
formation.(5) Among these, Malassezia globose and Malassezia
restricta are recognized as the most important pathogenic organisms in the
development of dandruff.[6] In
the current scenario many chemical substances are in use for treating dandruff
and these agents have certain limitation such as recurrence of dandruff and
their harmful effects on skin after using it for long period are common. Gunjaadi
Taila and Bhringarajaadi Taila are medicinal preparations mentioned
in Yogaratanakara which are small and simple preparations being used in Darunaka.
All ingredients of both Taila are easily available and cheaper in
cost so every patient can afford easily. Comparison of Gunjaadi Taila,
Kantkari Taila and Tila Taila has been done in our department
previously in which GunjadiTaila found more effective in comparison to Kantkari
Taila and Tila Taila.So we are comparing here Bhringarajaadi Taila
with Gunjaadi Taila. Therefore, this study is planned to evaluate and
compare the efficacy of Bhringarajaadi Taila and Gunjaadi Taila
in the patients of darunaka (dandruff). |