| CTRI Number |
CTRI/2023/08/056784 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| 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
|
Clinical trial to evaluate the role of Jyotishmati taila in the management of Sidhma Kushta (Tinea versicolor) |
|
Scientific Title of Study
|
"A Randomised Controlled Clinical Trial To Evaluate The Role Of Jyotishmati Taila In The Management Of Sidhma Kushta Vis-A-Vis Pityriasis Versicolor" |
| 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 SUDESH K S |
| Designation |
PG SCHOLAR |
| Affiliation |
MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES |
| Address |
Muniyal Institute Of Ayurveda Medical Sciences
34/C, Shivalli, Industrial area, Manipal, Udupi District
Udupi
KARNATAKA
576104
India |
| Phone |
9686453173 |
| Fax |
|
| Email |
Sudeshsukumar98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRAMOD SHET B |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES |
| Address |
Muniyal Institute Of Ayurveda Medical Sciences
34/C, Shivalli, Industrial Area, Manipal, Udupi District
Udupi
KARNATAKA
576104
India |
| Phone |
7204557179 |
| Fax |
|
| Email |
pramodshetb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUDESH K S |
| Designation |
PG SCHOLAR |
| Affiliation |
MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES |
| Address |
Muniyal Institute Of Ayurveda Medical Sciences.
34/C, Shivalli, Industrial area, Manipal, Udupi District
Udupi
KARNATAKA
576104
India |
| Phone |
9686453173 |
| Fax |
|
| Email |
sudeshsukumar98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Muniyal Institute Of Ayurveda Medical Sciences, Manipal |
|
Primary Sponsor
Modification(s)
|
| Name |
Muniyal institute of ayurved |
| Address |
Muniyal Institute Of Ayurveda Medical Scienses.
34/C, Shivalli Industrial area Manipal Udupi - 576104 |
| 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 SUDESH K S |
MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES |
Out Patient Department- Kayachikitsa,
Room NO.4, Ground Floor. 34/C, Shivalli Industrial area, Manipal - 576104
Udupi
KARNATAKA |
9686453173
Sudeshsukumar98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES, MANIPAL INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B360||Pityriasis versicolor. Ayurveda Condition: SIDHMAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Ashtanga Hridaya , Procedure details: External application of Jyotishmati taila over the affected part & retained for minimum 30 minutes.
Dose: Twice daily (Morning and Night) quantity sufficient to cover affected site
Duration: 30 days.
)
(1) Medicine Name: Jyotishmati Taila, Reference: Ashtanga Hridaya, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(mg), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Chakradatta, Procedure details: External application of Gandhakadi Lepa over the affected part & retained for minimum 30 minutes
Dose: Twice daily (Morning and Night) q.s to cover affected site
Duration: 30 days.
)
(1) Medicine Name: Gandhakadi Lepa, Reference: Chakradatta, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(mg), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with classical signs and symptoms of Sidhma Kushta
2. Patients with positive KOH test for fungal dermatophytes
3. Patients belonging to either gender will be included
4. Persons willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy and lactation
2.Patients having P.versicolor with lacerated wounds and associated with secondary bacterial infections and major skin problems
3.Patients suffering from uncontrolled systemic disorders which worsen the conditions ( eg: DM, HIV etc )
4.Patients presenting with hypopigmentary disorders of skin other than Pityriasis versicolor
5.Patches caused due to burns, chemical explosion etc.
6.Patients who are on topical & systemic antifungal therapy for the same problem
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the itching |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To minimize the scaly flakes & patch size |
30 days |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/08/2023 |
| Date of Study Completion (India) |
11/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="3" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL
TO EVALUATE THE ROLE OF JYOTISHMATI TAILA IN THE MANAGEMENT OF SIDHMA KUSHTA VIS-À-VIS PITYRIASIS VERSICOLOR
Jyotishmati
taila is one of the classical preparation mentionedin Ashtanga Hridaya for Sidhma
kushta. It contains alkaline water of Apamarga (Achyranthes aspera)
and oil extracted seeds of Celastrus paniculatus. Various studies shows
that this oil is having antioxidant, antibacterial, antifungal and
hypolipidemic properties and found
highly significant in tissue epithlialization. The oil
in combination with Apamarga Kshara is known to have Kapha hara
action and Sidhma nashaka. But the efficacy of the formulation is not
documented. Hence effort has been made to evaluate the efficacy of topical
application of Jyotishmati Taila in the management of Sidhma kushta. In this study 40 subjects, 20 in each group will be selected as per inclusion and exclusion criteria. Group A (study group) - 20 subjects will be subjected to external
application of Jyotishmati taila over the affected part and retained for
minimum 30 minutes Dose: Twice daily
(Morning and Night) q.s to cover affected site Duration: 30 days. Group B (control group) - 20 subjects will be subjected to external
application of Gandakadi lepa over the affected part and retained for
minimum 30 minutes Dose: Twice daily
(Morning and Night) q.s to cover affected site Duration: 30 days.
Treatment
period: 30 days (Clinical assessment
will be done on 15thand 30th day of treatment)
Follow up Period: Will be on 45th & 60th
day of the treatment.
|