| CTRI Number |
CTRI/2025/02/080680 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare efficacy of nasya karma with Prapaundarikadi taila and Shadbindu taila as Nasya karma in the management of Darunaka |
|
Scientific Title of Study
|
A Randomized Open Labelled Comparative Clinical Study To Evaluate The Efficacy Of Nasya Karma With Prapaundarikadi Taila And Nasya Karma With Shadbindu Taila In Darunaka |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sampada Shantgonda Patil |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri college of Ayurvedic Science and Research Hospital |
| Address |
Room No.-8,Panchakarma OPD,Sri Sri College of Ayurvedic science and Research Hospital,21st K.M.Kanakapura Road,Udayapura.Bengalore Karnataka 560082 India
Bangalore
KARNATAKA
560082
India |
| Phone |
9449407311 |
| Fax |
|
| Email |
psampada99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prajwal Narayan |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Room No.-8,Panchakarma OPD,Sri Sri College of Ayurvedic science and Research Hospital,21st K.M.Kanakapura Road,Udayapura.Bengalore Karnataka 560082 India
Bangalore
KARNATAKA
560082
India |
| Phone |
8951072206 |
| Fax |
|
| Email |
Prajwal.ayurveda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajwal Narayan |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Room No.-8,Panchakarma OPD,Sri Sri College of Ayurvedic science and Research Hospital,21st K.M.Kanakapura Road,Udayapura.Bengalore Karnataka 560082 India
Bangalore
KARNATAKA
560082
India |
| Phone |
8951072206 |
| Fax |
|
| Email |
Prajwal.ayurveda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic science
and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA
560082
India |
|
|
Primary Sponsor
|
| Name |
Dr.Sampada Shantgonda Patil |
| Address |
Sri Sri College of Ayurvedic Science and Research Hospital,Bengalore |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sampada Shantgonda Patil |
Sri Sri College of Ayurvedic science and Research Hospital,Bengalore |
Room no-8, Panchakarma OPD, Sri Sri College of Ayurvedic science
and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA
560082
India
Bangalore
KARNATAKA |
9449407311
psampada99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutinal Ethics Committee |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Prapaundarikadi Taila, Reference: Ashtanga Hridaya, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Shadbindu Taila, Reference: Bhaishajya Ratnavali, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
subjects of age group 21-50 yeas,irrespective of occupation and socio economic status.Subjects with Lakshana of darunaka.Subjects of either gender who are Nasya Yogya.Subject who are willing to give a written consent and participate in the study |
|
| ExclusionCriteria |
| Details |
1. Subjects who are Nasya Ayogya.
2. Subjects with other types of Kapala Rogas.
3. Subjects who are having other local and systemic disorders which interfere with the treatment.
4. Subjects associated with other dermatological conditions such as Psoriasis, Atopic dermatitis, Systemic lupus erythematous.
5. Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant decrease in Lakshana of Darunaka as assessed based on subjective parameters.
|
0th day, 7th day and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Generation of in-depth analysed data on the different aspect of the disease.
Generation of data on possible unexpected drug reactions/events.
|
nil |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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 Yet Recruiting |
| 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
|
The
term “Darunaka” refers to a skin condition
explained by Vagbhata in Kapalagata
Roga ,commonly
known
as “Dandruff”. In Ayurveda
different texts has categorized diseases and conditions differently based on
their etiology, symptoms and treatment approach. Darunaka is classified under
different Adhyayas in
various Ayurvedic texts. Acccording to Acharya Vagbhata, Darunaka
is primarily caused by the vitiation of Vata
and Kapha
Dosha and Lakshana’s of Darunaka are Kandu(itching),
Rukshata(dryness
or
roughness of scalp), Twaksputana(breaking/cracking
of skin on the scalp), Keshachyuti(falling
of hair).Dandruff
is an irritative
disease of the scalp in which shedding of dead tissue
from the scalp with itching sensation is the cardinal feature. Dandruff is much
more common, and affects approximately 50% of the general adult population
worldwide and it starts at puberty, reaches peak incidence and severity at the
age of about 20 years, and become less prevalence among people over 50 years.The
Chikitsa
of Darunaka
includes
Snehana,
Swedana,
Abhyanaga,
Siravyada,
Nasya, Shirobasti,
Prakshalana and Lepa.
In Panchakarma,
Nasya
Karma is
very important therapeutic procedure. It is the best method to alleviate the
vitiated Doshas
of
Uttamanga.
Acharya Vagbhata has
mentioned Nasya
Karma as
one
of the treatments of Darunaka. |