| CTRI Number |
CTRI/2021/02/031602 [Registered on: 26/02/2021] Trial Registered Prospectively |
| Last Modified On: |
26/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A STUDY FOR THE MANAGEMENT OF SCALP PSORIASIS WITH THE LOCAL APPLICATION OF NEEM OIL (AZADIRACHTA INDICA) |
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF NIMBA TAILA SHIROBHYANGA IN MANAGEMENT OF KITIBHA KUSHTA W.S.R TO SCALP PSORIASIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr NANDINI M |
| Designation |
DOCTOR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
DEPARTMENT OF PG STUDIES IN SWASTHAVRITTA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH, 21ST KM, KANAKAPURA ROAD, UDAYAPURA POST, BANGALORE
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
7353969974 |
| Fax |
|
| Email |
nandinin059@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SAJITHA K |
| Designation |
DOCTOR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
HOD AND PROFESSOR, DEPARTMENT OF PG STUDIES IN SWASTHAVRITTA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH, 21ST KM, KANAKAPURA ROAD, UDAYAPURA POST, BANGALORE
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9448415810 |
| Fax |
|
| Email |
sajithak96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NANDINI M |
| Designation |
DOCTOR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
DEPARTMENT OF PG STUDIES IN SWASTHAVRITTA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH, 21ST KM, KANAKAPURA ROAD, UDAYAPURA POST, BANGALORE
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
7353969974 |
| Fax |
|
| Email |
nandinin059@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Nandini M
PG SCHOLAR
DEPARTMENT OF PG STUDIES IN SWASTHAVRITTA
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH
21ST KM
UDAYAPURA
BANGALORE-560082 |
|
|
Primary Sponsor
|
| Name |
Dr NANDINI M |
| Address |
DEPARTMENT OF PG STUDIES IN SWASTHAVRITTA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH, 21ST KM, KANAKAPURA ROAD, UDAYAPURA POST, BANGALORE - 560082 |
| Type of Sponsor |
Private medical college |
|
|
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 NANDINI M |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
DEPARTMENT OF PG STUDIES IN SWASTHAVRITTA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH, 21ST KM, KANAKAPURA ROAD, UDAYAPURA POST, BANGALORE
Bangalore Rural
KARNATAKA |
7353969974
nandinin059@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: KITIBAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
kutaja patra taila shirobhyanga |
Patient is made to sit in a comfortable position, by using 15ml of sukhoshna taila shirobhyanga is done for a duration of 15minutes. It is carried out by using tip of the fingers, gently massage over the scalp and take head bath. |
| Intervention |
nimba taila shirobhyanga |
Patient is made to sit in a comfortable position, by using 15ml of sukhoshna taila shirobhyanga is done for a duration of 15 minutes. It is carried out by using tip of the fingers, gently massage over the scalp and take head bath. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject who are clinically diagnosed with mild to moderate scalp psoriasis.
2. Subject of the age group between 21 to 60 years will be included irrespective of their gender, religion, marital status and socioeconomic status.
3. Subjects with duration of disease less than 3years.
4. Subjects who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who are having psoriatic lesions other than scalp.
2. Subjects with severe scalp psoriatic symptoms.
3. Subjects who are under any medication for scalp psoriasis.
4. Subjects who are pregnant and lactating.
5. Subjects who are not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the efficacy of Nimba taila shirobhyanga in the management of scalp psoriasis.
2. To re-evaluate the efficacy of Kutaja patra taila shirobhyanga in the management of scalp psoriasis.
3. To compare the efficacy of Nimba taila shirobhyanga and Kutaja patra taila shirobhyanga in the management of scalp psoriasis.
|
Pre-Study Assessment - 0 Day
1st Assessment - 15th Day
1st Follow up - 30th Day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction of hair fall |
Pre-Study Assessment - 0 Day
1st Assessment - 15th Day
1st Follow up - 30th Day
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2021 |
| 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
|
not yet published |
|
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nandinin059@gmail.com].
- For how long will this data be available start date provided 30-01-2021 and end date provided 30-01-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Skin is the largest
organ in the body and the first medium of protection. Any
condition related to skin affects emotional and mental well-being of a person
in turn affecting the self-confidence causing social stigma and reducing his
productivity to the society. Working professionals are more conscious about
their external beauty, some professional fields demand good looks. Psoriasis
affects the social health of individual by causing discomfort and disfigurement. Kitibha kushta is one of the kshrudra kushta
having the lakshanas like shyava, kina khara sparsha,
parusha and kandu. Kitibha kushta
manifests due to the vitiation of sapta dusyas i.e. vata, pitta,
kapha, twak, rakta, mamsa and lasika. Scalp
psoriasis is a common skin disorder characterized by raised, reddish, often
scaly patches. It can pop up as a single patch or several, and can even affect
the entire scalp. It predominantly seen in margin of hair, the back of the neck
or behind and inside the ears. Shirobhyanga is one among the four types of murdhni taila
and one of the subtype of bhahya snehana. Shirobhyanga can be considered as secondary prevention and
is one among the dinacharya procedure |