| CTRI Number |
CTRI/2024/09/073896 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Vishagna Oil in the treatment of Dandruff |
|
Scientific Title of Study
|
Effect of Nimbaneelyadi Taila in Darunaka A Randomized Controlled
Clinical Trial |
| 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 Ruksana P K |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BM Kankanawadi Ayurveda Hospital and Research Centre Shahapur Belagavi |
| Address |
Department of Agadatantra
KAHERs Shri BM Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9745438553 |
| Fax |
|
| Email |
pkruksanarukku@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rudramma R Hiremath |
| Designation |
Professor and HOD |
| Affiliation |
KAHERs Shri BM Kankanawadi Ayurveda Hospital and Research Centre Shahapur Belagavi |
| Address |
Department of Agadatantra
KAHERs Shri BM Kankanawadi
Ayurveda Mahavidyalaya Shahapur
Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9480539098 |
| Fax |
|
| Email |
drrrhiremath99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rudramma R Hiremath |
| Designation |
Professor and HOD |
| Affiliation |
KAHERs Shri BM Kankanawadi Ayurveda Hospital and Research Centre Shahapur Belagavi |
| Address |
Department of Agadatantra
KAHERs Shri BM Kankanawadi
Ayurveda Mahavidyalaya Shahapur
Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9480539098 |
| Fax |
|
| Email |
drrrhiremath99@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri BM Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Ruksana P K |
| Address |
Department of Agadatantra
KAHERs Shri BM Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi |
| 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 Ruksana P K |
KLE Ayurveda Hospital Belagavi |
OPD number 16
Department of Agadatantra
Belgaum
KARNATAKA |
9745438553
pkruksanarukku@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects KAHERs Shri BM Kankanawadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital Shahapur Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L219||Seborrheic dermatitis, unspecified. Ayurveda Condition: DARUNAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimbaneelyadi taila, Reference: Prayoga samuchaya and Visha vaidya jyotsnika,thritheeyaparicheda,mandali samanya chikitsa page no.65, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -The patient advised to apply the oil after sunset and the next day morning hair should bewashed with luke warm water.No shampoo will be advised. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Durdhurapathradi kerataila, Reference: Sahasrayogam-taila yogas,English translation by Dr.M.S krishnamurthy,first edition,2021,chaukhamba orientala., Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -No, Additional Information: The patient advised to apply the oil after sunset and the next day morning hair should bewashed with luke warm water.No shampoo advised. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1 Subject presented with classical features of Darunaka as mentioned in diagnostic criteria will be selected
2 Patient who has willing to enroll for the study
3 Age group 18 to 40 years will be recruited
4 Subjects of either gender will be recruited |
|
| ExclusionCriteria |
| Details |
1 Associated with other dermatological conditions like seborrheic dermatitis scalp psoriasis and other infections
2 Darunaka as a complication of systemic diseases
3 Patient with history of hypersensitivity immunodeficiency and known drug allergies
4 Subject having chronic infectious diseases like tuberculosis leprosy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Scaling of scalp by Trichoscopy
2) Adherent scalp flaking score |
Baseline and 45th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Dryness of scalp
2.Itching of scalp
3.Hair fall
|
Baseline 20th and 45th day |
|
|
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) |
17/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
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
|
Dandruff is a non-inflammatory disease of the scalp with symptoms like itching, visible flakes, and hair fall. Post pubertal population (aged 18 to 60) is the most vulnerable age group to this issue. It has been noted that all population across the globe eventually develops Dandruff at least once in their lifetime.The prevalence of Dandruff in South Asia is 60.1%, whereas in the world it is 50%. Worldwide and particularly in Indian cities, pollution levels are rising.Dandruff, redness, itching, irritation of the scalp, excessive sebum production, soreness in the hair roots, and hair loss can all be caused by air pollution, the exponential rise in air pollution leads to a rise in gases like Sulfur dioxide (SO2), nitrogen dioxide (NO2), ammonia (NH3), and other gases that can cause hair damage and Dandruff. The scenario will be worsen during winter, smog etc which can even be three to five times higher. Over the past decade, the hair cosmetics sector has seen a revolutionary upheaval. Nowadays, not only Simple cleansing is the focus, but also mending, increasing tensile strength, and promoting attractiveness are also prioritized. Wax, gel, hair dyes, and hair spray, hair oils, shampoos are used widely as hair cosmetics. These items contain chemicals like Parabens, Sulphates, PEG, Phthalates, Fragrance, and Heavy Metals like Lead, Mercury, Titanium, etc., which are hazardous to the hair, scalp as well as human body . These hair care products will increase the incidence of hair cosmetic toxicity and eventually can be absorbed by the scalp and lead to scalp build up adding to dandruff. Many hair shampoos that have higher alkaline pH may increase the negative electrical charge of the hair fiber surface and, therefore, increase friction between the hair fibers. This may lead to cuticle damage and hair fiber breakage. Lower pH of shampoos may cause less frizzing for generating less negative static electricity on the hair fiber surface. Only 38% of the popular brand shampoos against 75% of the salon’s shampoos presented a pH ≤ 5.0. and imbalance in pH levels can cause dandruff, oily scalp and dull hair. In agada tantra, these all causative factors are included under Gara Visha which is the main cause of Darunaka. In the classics, Darunaka is explained as one of the Kshudra roga and kapalagata roga having vata-kapha predominant doshas. The clinical features of Dandruff are closely similar to Darunaka. Due to a sedentary lifestyle, people hardly have time for Nidana Parivarjana. Hence a remedy that acts on vitiated kapha and vata doshas, and at the same time strengthening of hair is needed to counter Darunaka. Nimbaneelyadi yoga is one simple Vishaghna yoga that is not much explored and used for managing visa conditions. Nimbaneelyadi yoga is mentioned in Prayoga Samuchaya & in Vishavaidya jyotsnika . This yoga can be prepared in lepa, Kashaya, taila, etc. different forms and is said to be used in different visha conditions. The ingredients of Nimbaneelyadi yoga are Nimba mula (Azadirachta indica A. Juss), Nili mula (Indigofera tinctoria Linn), and Karanja mula (Pongamia pinnata Linn). They have kapha vatahara, kushtagna, krimigna, kandugna, keshya, and vishagna properties. All ingredients are effective in Darunaka individually and scientific research data showed effect in Darunaka. But its effect in combination is need of hour and is currently not available in the market. Hence, the present study has been planned to evaluate the clinical effect of Nimbaneelyadi yoga in taila form against Darunaka. |