| CTRI Number |
CTRI/2024/08/072425 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study To Access The Efficacy Of Kadalikshar Lepa In The Management of Sidhma Kushta With Special Reference
TINEA VERSICOLOR IN CHILDREN. |
|
Scientific Title of Study
|
Single Arm Clinical Study To Access The Efficacy Of Kadalikshar Lepa
In The Management Of Sidhma Kushtha With Special Reference To
Tinea Versicolor 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 Pramod shelke |
| Designation |
Pg scholar |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center |
| Address |
LRP Ayurvedic Medical College and hospital PG Institute and Research Centre Urun Islampur kaumarbhritya department OPD 2 Sangli
MAHARASHTRA
415409
India
Sangli
MAHARASHTRA
415409
India |
| Phone |
7058555586 |
| Fax |
|
| Email |
Pramodshelke90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Masaudaalam Mujawar |
| Designation |
HOD and Professor |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center |
| Address |
LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur, kaumarbhritya department, OPD 2 Sangli
MAHARASHTRA
Sangli
MAHARASHTRA
415409
India |
| Phone |
9823645588 |
| Fax |
|
| Email |
dr.masudaalam10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Masaudaalam Mujawar |
| Designation |
HOD and Professor |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center |
| Address |
LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur, kaumarbhritya department, OPD 2 Sangli
MAHARASHTRA
Sangli
MAHARASHTRA
415409
India |
| Phone |
7058555586 |
| Fax |
|
| Email |
Pramodshelke90@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Aurvedic medical college and hospital, PG Institute and Research center, Urun Islampur 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Pramod shelke |
| Address |
LRP Aurvedic medical college and hospital, PG Institute and Research center, Urun Islampur 415409 |
| 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 Pramod Shelke |
LRP Ayurvedic Medical College and Hospital |
LRP Aurvedic medical college and hospital, PG Institute and Research center, Urun Islampur, Sangli, Department of kaumarbhritya, OPD 2 Sangli MAHARASHTRA
Sangli
MAHARASHTRA |
7058555586
Pramodshelke90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Loknete Rajarambapu Patil Ayurved Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: SIDHMAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kadali kshar Lepa, Reference: GadaNigraha, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Only for local application |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with Sidhma kushtha.
-Children between 8- 14 years of age group irrespective of
sex, caste, religion and socioeconomic status. |
|
| ExclusionCriteria |
| Details |
Children suffering with known case of any autoimmune disorder.
-Children with known case of chronic skin disease other than Sidhma or allergic
skin disease.
-Children of Sidhma Kushtha with Secondary infections. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of “kadalikshar Lepa†in the management of Sidhma Kushtha
With special reference to Tinea versicolor in children . |
21 days study with follow up on 7th 15th 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study the efficacy of “Kadalikshar Lepaâ€in children with Ayurvedic
perspective in detail.
2) To study the literature related to Sidhma Kushtha.
3) To study the etiopathogenesis of ‘Sidhma kushtha’in children from ayurvedic &
contemporary medical literature.
4) To study the concept of Lepa preparation. |
21 days study with follow up on 7th 15th 21st 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 |
|
Date of First Enrollment (India)
|
23/08/2024 |
| 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="6"
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
|
about skin. In Ayurveda all the skin disorders are described under the single heading called Kushtha Sidhma is one of the type of Kushtha which comes under Mahakushtha as per Acharya CHARAKA where Acharya SUSHRUT mentioned Sidhma in Kshudrakushtha Acording to Charaka Sidhma is characterized by browny deglutination having white and copper colour. The lesion are very thin and most commonly present on the chest shoulder face and proximal extremities Sidhma Kushtha with special reference to Tinea Versiclor Pityriasis Versicolor is a disorder characterized by rash over trunk and proximal extremities which is caused by malassezia furfur/malassezia globusa fungas In infants and young children lesions are often located on the face Many Ayurvedic drug formulations such as KadaliKsharLepa which includes Kadalikshar Haridra are effective in management of Sidhma since Samhita period.Prasently used drugs like selenium sulphide 2 point 5 percent lotion and 1 percent clotrimazole or Imdazole are also effective in the treatment of Tinea Versicolor |