| CTRI Number |
CTRI/2024/04/065641 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical efficacy of Hopea parviflora Bedd. in Alasa( Tinea pedis) |
|
Scientific Title of Study
|
Pharmacognostical,Phytochemical study of Hopea parviflora Bedd. and its clinical efficacy in Alasa (Tinea pedis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrKshama Jain |
| Designation |
Postgraduate scholar |
| Affiliation |
Alvas Ayurveda medical College and Hospital,Moodabidri, DK district |
| Address |
Department of PG studies in Dravyaguna Vijnana
Alvas Ayurveda Medical College and Hospital
Moodabidri DK district
Omkaara,near Omkaar Printers,SM college road, kodangallu post, Moodbidriu post
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7022711225 |
| Fax |
|
| Email |
drkshamajain05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Subrahmanya P |
| Designation |
Professor & H.O.D. |
| Affiliation |
Alvas Ayurveda medical College and Hospital,Moodabidri, DK district |
| Address |
Department of PG studies in Dravyaguna Vijnana
Alvas Ayurveda Medical College and Hospital
Moodabidri DK disrtict
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9448327156 |
| Fax |
|
| Email |
drsp28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrKshama Jain |
| Designation |
Postgraduate scholar |
| Affiliation |
Alvas Ayurveda medical College and Hospital,Moodabidri, DK district |
| Address |
Department of PG studies in Dravyaguna Vijnana
Alvas Ayurveda medical College and Hospital
Vidyagiri Moodabidri, DK disrtict
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7022711225 |
| Fax |
|
| Email |
drkshamajain05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College & Hospital Vidyagiri
Moodabidri DK district. 574227 |
|
|
Primary Sponsor
|
| Name |
Alvas Ayurveda Medical college & Hospital |
| Address |
Alvas Ayurveda Medical college & Hospital, Moodabidri, DK district.574227 |
| 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 |
| DrKshama Jain |
Alvas Ayurveda Medical College and Hospital |
Skin OPD,
Department of PG studies in Dravyaguna Vijnana
AAMCH, Vidyagiri, Moodabidri
Dakshina Kannada
KARNATAKA |
7022711225
drkshamajain05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee Alvas Ayurveda Medical College |
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: ALASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Standard Group | Patients suffering from Alasa(Tinea pedis) will be given Clotrimazole 1% ointment for topical application. | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Tila taila -Bee wax ointment, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: Patients suffering from Alasa(tinea pedis) will be given ointment prepared from Tila taila(sesame oil) and bee wax for topical application. | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Hopea parviflora Ointment, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: Patients suffering from Alasa(Tinea pedis) will be given ointment prepared from the stem bark of Hopea parviflora Bedd., Tila taila and bee wax for topical application |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex, between the age group of 16-60 years who will fulfill the diagnostic criteria will be taken up for the study |
|
| ExclusionCriteria |
| Details |
Patients suffering from systemic diseases, Patients taking immuno-suppresive medications, lesions with secondary infections |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
patient will be assessed on the improvement in clinical features.
pateints will be assessed as per the subjective parameters- kandu(pruritis), Daha( burning sensation), Ruja( pain) and objective parameters- maceration and fissuring. |
patients will be assessed once in 7 days i.e. on 7th, 14th, 21st, 28th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient will be assessed on the improvement in clinical features. |
patient will be assessed once in 14days during the follow up period |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/04/2024 |
| 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="0"
Months="4"
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
|
Dermatophytosis also known as Tinea is a fungal infection of the skin. Prevalence of dermatophyte infection in South India is nearly about 27.6%. One such dermatophyte infection commonly seen in the coastal belt of Karnataka is Tine pedis. Environmental factors, agrarian workforce and food habits contribute for the prevalence of this disease in South Canara region. Tinea pedis is the superficial fungal infection affecting the feet, especially inter-digital web spaces. It can be near co-related with Alasa. Alasa is one among the Kshudra rogas mentioned in the Ayurvedic literatures. The growing resistance for the anti-fungal agents in the present scenario has led to rise in the identification of safe herbal drug or formulation which is economical and easily available. Dipterocarpaceae is dominant family in the evergreen forests of India which are well known for timber, but less acknowledged for its medicinal importance. There is mentioning of few dipterocarpaceae drugs in Ayurvedic texts which are proved potent against many skin diseases. One such dipterocarpaceae member found continuous and through out Western Ghats is Hopea parviflora Bedd. Leaves and stem bark of Hopea parviflora Bedd. are in use in the folklore practice of South Canara. Folklore medicine has given rich contribution to the development of materia-medica of Ayurveda. Integrating these traditional knowledge into mainstream healthcare would require research to understand the efficacy, safety and mechanism of action of traditional medicine. Hence an effort is made to scientifically authenticate the efficacy of drug Hopea parviflora Bedd. in Alasa(Tinea pedis). |