| CTRI Number |
CTRI/2024/06/069564 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To Study the Efficacy of Priyalbeejadi Lepa in the Management of Darunaka w.s.r Pityriasis Capitis |
|
Scientific Title of Study
|
A Randomized Open Labelled Controlled Clinical Study to evaluate the Efficacy of Priyalbeejadi Lepa in the Management of Darunaka w.s.r Pityriasis Capitis |
| 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 DEEKSHANT THAKUR |
| Designation |
PG SCHOLAR |
| Affiliation |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU |
| Address |
P.G. DEPARTMENT OF KAYACHIKITSA,JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI,JAMMU,JAMMU AND KASHMIR
Jammu JAMMU & KASHMIR 181123 India |
| Phone |
9103709219 |
| Fax |
|
| Email |
thakurdeekshant9295@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR POONAM GUPTA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU |
| Address |
P.G. DEPARTMENT OF KAYACHIKITSA,JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI,JAMMU,JAMMU AND KASHMIR
Jammu JAMMU & KASHMIR 181123 India |
| Phone |
9149696904 |
| Fax |
|
| Email |
drpoonamgupta03@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR POONAM GUPTA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU |
| Address |
P.G. DEPARTMENT OF KAYACHIKITSA,JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI,JAMMU,JAMMU AND KASHMIR
Jammu JAMMU & KASHMIR 181123 India |
| Phone |
9149696904 |
| Fax |
|
| Email |
drpoonamgupta03@gmail.com |
|
|
Source of Monetary or Material Support
|
| JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI ,JAMMU,JAMMU AND KASHMIR 181123 INDIA |
|
|
Primary Sponsor
|
| Name |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU |
| Address |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI ,JAMMU,JAMMU AND KASHMIR 181123 INDIA |
| 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 DEEKSHANT THAKUR |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU |
P.G. DEPARTMENT OF KAYACHIKITSA,OPD and IPD of hospital,NARDNI, JAMMU, JAMMU AND KASHMIR- 181123 Jammu JAMMU & KASHMIR |
9103709219
thakurdeekshant9295@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU |
Approved |
|
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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 | Procedure | - | lepa, लेप | (Procedure Reference: Shribhava Prakash , Procedure details: Initially the patient will be advised to clean the head with cold water. Application of Aamrabeeja Haritaki Churna is mixed with Milk to form thick paste and is applied on the affected areas. Thickness of the Lepa-1/4 angula Patient is asked to wash the head with cold water before the lepa dries. Application of lepa for 30 days on alternative days)
| | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Astang Samgraha Uttarsathana 28/33 , Procedure details: Initially the patient will be advised to clean the head with cold water. Application of Priyalbeejadi churna mixed with Madhu to form thick paste and is applied on the affected areas. Thickness of the Lepa-1/4 angula Patient is asked to wash the head with cold water before the lepa dries. Application of lepa for 30 days on alternative days)
|
|
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects aged between 16-40 years.
2.Patient representing signs and symptoms of Darunaka who will be willing to participate in the study.
3.Subjects willing to participate with written informed consent, which is conveyed in the language which the subject can understand.
|
|
| ExclusionCriteria |
| Details |
1.Eczema of scalp.
2.Psoriasis of scalp.
3.Immune- compromised conditions.
4.Conditions in which head wash is restricted like Pratishyaya , injuries to scalp etc.
5.Pregnant and lactating women.
6.Subjects with uncontrolled systemic illness including diabetes mellitus, hypertension.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients of both sexes age group 16 to 40 years of Darunaka will be selected for relieving sign and symptoms |
Patients of both sexes age group 16 to 40 years of Darunaka will be selected for relieving sign and symptoms |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| Date of Study Completion (India) |
07/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="1" Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Ayurveda is the first and foremost spiritual science that offers a scientific approach to live in harmony with nature. Ayurveda is the most ancient healing science and ideal approach for an appropriate life style. According to this science, proper choice of Ahara and Vihara helps to achieve healthy life by maintaining and / or restoring equilibrium of the body and mind. In Ayurveda, Shira is said to be root of the plant for possessing all special senses and Prana, so one has to protect and care the Shira. Acharyas have explained different Shiroroga out of which Darunaka is one among them. Acharya Vagbhata have described 19 Shiroroga out of which 9 are Shirokapalaroga and “Darunaka†is one among them. Acharya Sushruta has included “Darunaka†under Kshudrarogas. It is a Roga affecting mainly the Kapala, that is scalp and it also hampers the normal healthy status of hair.Shirapradeshi Kandu (itching), Rukshata (dryness), Shirotwaka Sphutanam (cracking of the scalp skin with fine flakes), and Keshachyuti (hair-fall) are the cardinal symptoms of Darunaka which involves mainly vitiated Vata and Kapha Doshas. Darunaka can be correlated with Pityriasis capitis also referred to as Pityriasis simplex capitis, it is generally referred to as Dandruff. Pityriasis capitis is a disease characterized by itchy scalp and flakiness .Several microbial and non-microbial etiologies are considered for pathogenesis. Increased presence of Malassezia restricta has been reported as the key microbial etiological factor. Increased sebaceous gland activity, decreased skin hydration, skin irritation, immune suppression, or oxidative stress have also been proposed as non-microbial etiologies. Due to frequent recurrences, Pityriasis Capitis represented as a very common dermatologic scalp condition in a wide range of population with estimating prevalence of 60.1% in South Asia, whereas 50% worldwide.Pityriasis Capitis is a scalp disorder affecting more than half of the global population. A survey in the United States showed that 50 million people suffer from dandruff annually and the prevalence is sharply increasing due to rapid urbanization.It occurs more frequently in adolescents, young adults.
Pityriasis Capitis is a scalp disorder with high rate of prevalence .There are many market preparations which are advised by modern dermatologists but it has some limitations as the effect is not long-lasting or cost of treatment is very high. As satisfactory results are not available, Patients are continuously looking with hope towards Ayurveda. Ayurveda plays an important role in the management of Darunaka as its unique treatment modality provides long-lasting results through three basic principles of treatment that is Nidana Parivarjana, Shodhana Chikitsa, and Shamana Aushadhis. Sthanika Chikitsa in terms of Lepa and Dhavana is also important in order to relieve the symptoms and nourish the hair.In present study one such formulation of Lepa which is given in Astang Samgraha Uttarsathana 28/33 is Priyalbeejadi Lepa(Trial drug) is taken to assess its efficacy on Darunaka wsr to Pityriasis Capitis and compared with Aamrabeeja Haritaki Lepa (controlled) |