| CTRI Number |
CTRI/2025/04/085715 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on the effectiveness of Trunakadi taila and Khadirarishata for treating ringworm infestation in children |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of Trunakadi taila and Khadirarishta in Dadru Kushta Dermatophytosis in children |
| 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 Piyush Popatrao Sonawane |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College And Hospital |
| Address |
JSS Ayurveda Medical College And Hospital Kaumarabhritya OPD 11 41 E Lalithadripura Road Alanahalli Mysuru 570028
Mysore KARNATAKA 570028 India |
| Phone |
8657762410 |
| Fax |
|
| Email |
piyushsonawane1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Srihari S |
| Designation |
Professor And Head Of The Department |
| Affiliation |
JSS Ayurveda Medical College And Hospital |
| Address |
JSS Ayurveda Medical College And Hospital Kaumarabhritya OPD 11 41 E Lalithadripura Road Alanahalli Mysuru 570028
Mysore KARNATAKA 570028 India |
| Phone |
7776077626 |
| Fax |
|
| Email |
Dr.srihari@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Piyush Popatrao Sonawane |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College And Hospital |
| Address |
JSS Ayurveda Medical College And Hospital Kaumarabhritya OPD 11 41 E Lalithadripura Road Alanahalli Mysuru 570028
Mysore KARNATAKA 570028 India |
| Phone |
8657762410 |
| Fax |
|
| Email |
piyushsonawane1997@gmail.com |
|
|
Source of Monetary or Material Support
|
|
3) Griseofulvin tablet and Terbinafine 1% ointment will be purchased from the local Pharmacy.
|
| 1) Raw material for the preparation of Trunakadi Taila will be procured from the local market after proper identification and authentication by Department of PG studies in Dravyaguna, JSSAMC&H, Mysuru, Karnataka India 570028 and will be prepared in GMP certified pharmacy. |
| 2) Khadirarishta will be purchased from GMP certified Ayurveda pharmacy. |
|
|
Primary Sponsor
|
| Name |
Dr Piyush Popatrao Sonawane |
| Address |
JSS Ayurveda Medical College And Hospital 41/E Lalithadripura Road Alanahalli Mysuru 570028 |
| 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 Piyush Popatrao Sonawane |
JSS Ayurveda Medical College And Hospital 41/E Lalithadripura Road Alanahalli Mysuru 570028 |
JSS Ayurveda Medical College And Hospital Kaumarabhritya OPD 11
41/E Lalithadripura Road Alanahalli Mysuru 570028 Mysore KARNATAKA |
8657762410
piyushsonawane1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B354||Tinea corporis. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Terbinafine 1% | External application for 2 weeks quantity sufficient | | 2 | Comparator Arm (Non Ayurveda) | | - | tablet griseofulvin | 20-25mg/kg/day for 2 weeks in BD dosage | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trunakadi taila, Reference: Vangasena, Route: Topical, Dosage Form: Taila, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: - | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kadhiraristha, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Arishta, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1 Age group - 3 to 15 years, irrespective of Gender, Religion, and Socio-Economic status.
2 Subjects suffering from infestation of Tinea Carporis and Tinea Cruris.
3 Subjects fulfilling the diagnostic criteria of Dadru Kushta (Dermatophytosis).
|
|
| ExclusionCriteria |
| Details |
1. Patients having chronic infection of Dadru Kushta for more than 3 years.
2. Subjects with any other skin manifestations.
3. Subjects with any other systemic disorders which may interfere with the course of study.
4. Subjects with Tinea Capitis, Tinea Barbae, Tinea Mannum, Tinea Pedis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the combined effect of Trunakadi Taila external application and Khadirarishta orally in clinical features of Dadru (Dermatophytosis) and quality of life parameters in children. |
0th day
8th day
15th day
30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To assess the effect of Terbinafine 1% ointment and Griseofulvin orally in clinical features of Dermatophytosis and quality of life parameters in children.
2 To compare the combined effect of Trunakadi Taila and Khadirarishta orally with that of Griseofulvin orally and Terbinafine 1% ointment in clinical features of Dadru (Dermatophytosis) and quality of life parameters in children.
|
0th day
8th day
15th day
45th day |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" 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
|
According to Acharya Charaka, Kandu (itching),
Raga (erythema), reddish coloured Pidaka are in the form of Udgata
Mandala (elevated circular lesion) is known as Dadru. Acharya Sushruta
has described Dadru as Kapha Pradhana Vyadhi (predominant),
and Acharya Vaghbhata and Charaka described it as Pitta Kapha Pradhana
Dosha. Lakshanas of Dadru Kushta that is Raukshya, Kandu, Daha,
Srava, Mandala. All the clinical features of Dadru can be
very well correlated to clinical features of Tinea. Tinea infections are known
as dermatophytosis or Ringworm. In Pediatric age group local application is the
best line of treatment in mild to moderate ringworm manifestation The
antifungal medications available in the market have some adverse effects on the
human body. So, there is a need of exploring a safe and effective medicine. In
modern medicine, it is treated with topical or systemic antifungal,
corticosteroids which gives very fast relief but with high recurrence rate,
whereas the systemic and local use of Ayurveda medicine has shown considerable
effect in reducing the recurrence rate in Dadru (Tinea). Dadru Kushta is managed by Shodhana, Shamana
and local application. The selected
formulation of the present study is Khadirarishta which will be given
orally and Trunakadi Taila for external application, as the ingredients
of above Yogas possess the properties such as Kushtaghna, Kandughna and
Twak Doshahara.
Primary objective of the study To evaluate the combined effect of Trunakadi
Taila external application and Khadirarishta orally in clinical
features of Dadru (Dermatophytosis). The secondary objective is To
compare the combined effect of Trunakadi Taila and Khadirarishta
orally with that of Griseofulvin orally and Terbinafine 1% ointment in
clinical features of Dadru (Dermatophytosis) and quality of life
parameters in children.The study hypothesize that Trunakadi taila and
Khadirarishta is as effective as standard care in managing Dadru (tinea)
|