| CTRI Number |
CTRI/2024/10/074823 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Tuvarak taila cream in the management of sidhma kushtha (Pityriasis versicolor) |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON TUVARAK TAILA CREAM AND 2 PERCENT TOPICAL KETOCONAZOLE IN THE MANAGEMENT OF SIDHMA KUSHTHA (PITYRIASIS VERSICOLOR) IN CHILDREN- AN OPEN LABELLED 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 Akshita Thakur |
| Designation |
PG SCHOLAR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Room no 408 Department of Kaumarbhritya Academic block All India
Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
9878681404 |
| Fax |
|
| Email |
akshitathakur084@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ved Prakash Vyas |
| Designation |
Professor Department of Kaumarbhritya |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Room no 404 Department of Kaumarbhritya Academic block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
9907513436 |
| Fax |
|
| Email |
Vedvyas61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshita Thakur |
| Designation |
PG SCHOLAR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Room no 408 Department of Kaumarbhritya Academic block All India
Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
9878681404 |
| Fax |
|
| Email |
akshitathakur084@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF AYURVEDA NEW DELHI |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
110076 |
| 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 Akshita Thakur |
All India Institute of Ayurveda |
Room no 408
Department of
Kaumarbhritya
Academic Block All
India institute of
Ayurveda Gautampuri
Sarita vihar New Delhi
110076
South
DELHI
South
DELHI |
9878681404
akshitathakur084@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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: SIDHMAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Tuvaraka Taila Cream, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Weeks, anupAna/sahapAna: No, Additional Information: Tuvaraka Taila Cream | | 2 | Comparator Arm (Non Ayurveda) | | - | 2% Ketoconazole Cream | Local application/Cream/Quantity Sufficient/ Frequency BD Duration 14 days |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between 10 to 16 years of age irrespective of gender.
2.Patients with clinical signs of the disease Sidhma Kushtha (Pityriasis Versicolor)-
Rajoghrishtma vimunchyati (Furferaceous scales)
Tamra Varna (Reddish black,brown coloured macules)
AlabupushpaVarna(Hypopigmentedmacules/hyperpigmented macules)
Kandu (Itching)
Urdhav kaye especially Uras (chest, trunk or neck)
Tanu (thin plaques)
3. Patients found positive for KOH test
4. Willing to give assent/consent for the trial
|
|
| ExclusionCriteria |
| Details |
1.Children with congenital anomalies, chronic ailments such as tuberculosis, malignancy, cardiac, and renal disorders, autoimmune disorder or any other systemic illness
2.Patient have received systemic antifungal therapy within 1 month or topical antifungal therapy within 1 week of the commensal of study.
3.Patients with vitiligo, leprosy, pityriasis rosea, psoriasis, pityriasis alba, tinea capitis, tinea cruris any other skin disease
4.Parents of the patient not willing to participate in the trial
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Antifungal effect of Tuvarak taila cream by performing KOH test.
2 Efficacy of Tuvarak taila cream in management of clinical features of Sidhma kushtha (pityriasis versicolor). Timeframe On 14th day/21st day (AT)and 42nd /49th day (FU). (Expected 90% improvement) and improvement in clinical features of Sidhma kushtha as per classical texts of Ayurveda
|
1 Antifungal effect of Tuvarak taila cream by performing KOH test.
2 Efficacy of Tuvarak taila cream in management of clinical features of Sidhma kushtha (pityriasis versicolor). i.e. Timeframe On 14th day/21st day (AT)and 42nd /49th day (FU). (Expected 90% improvement) and improvement in clinical features of Sidhma kushtha as per classical texts of Ayurveda
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Improvement in quality of life of the child as per Children’s Dermatological Life Quality Index (CDLQI) (Expected 90% improvement) |
AT (3weeks for group 1) & (2weeks for group 2) Follow Up After 4 weeks for both groups i.e.(7weeks for group 1) & (6weeks for group 2) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="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
|
RESEARCH TITLE- A comparative clinical study on Tuvarak Taila cream and 2% topical ketoconazole in the management of Sidhma kushtha (pityriasis versicolor) in children- An open labelled randomised controlled trial RESEARCH QUESTION: - What is the effect of local application of Tuvarak taila cream in comparison to 2% topical ketoconazole in the management of Sidhma kushtha (pityriasis versicolor) in adolescent children between 10 to 16 years of age. HYPOTHESIS Local application of Tuvarak taila cream will be more effective as compared to the localapplication of 2% ketoconazole cream in the management of Sidhma kushtha (pityriasis versicolor) in adolescent children between 10 to 16 years of age. NULL HYPOTHESIS Local application of Tuvarak taila cream is equally effective as compared to the local application of 2% ketoconazole cream in the management of Sidhma kushtha (pityriasis versicolor) in adolescent children between 10 to 16 years of age. ALTERNATIVE HYPOTHESIS Local application of Tuvarak taila cream is more effective as compared to the local application of 2% ketoconazole cream in the management of Sidhma kushtha (pityriasis versicolor) in adolescent children between 10 to 16 years of age
NEED OF THE STUDY- This disease although does not have any serious effects but have a widespread affect on the mental health of the child. The patients of the skin diseases are prone to experience physical, emotional and socio- economic embarrassment in the society due to disfigured appearance It significantly diminishes the confidence of adolescents, particularly given their heightened concern for appearance during this crucial developmental stage. Top of FormIt can affect the confidence and self esteem of the child,in turn hampering the academic performance and overall development of child.Child can become isolated and withdraw themselves from social interactions and may distance themselves from peers, family members, or others in their environment. Also, persistent recurrence of tinea versicolor poses a significant challenge, necessitating the formation of other formulations to effectively address this challenge. There are very limited studies on ayurvedic intervention in Sidhma kushtha in addition to that the palatability of ayurvedic drugs in children is an immensly challenging .Thus an attempt has been made on use of Tuvarak taila cream in management of Sidhma kushtha. PRIMARY OBJECTIVE · a) To compare the efficacy of Tuvarak taila cream applied for 3 weeks and 2% topical ketoconazole cream applied for 2 weeks in the management of Sidhma Kushtha (pityriasis versicolor) based on KOH examination and to assess the improvement in clinical features of Sidhma Kushtha as per classical texts of Ayurveda.
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