| CTRI Number |
CTRI/2020/03/024067 [Registered on: 19/03/2020] Trial Registered Prospectively |
| Last Modified On: |
05/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to evaluate the effect of Ayurvedic external application in treatment of Dadru-fungal infection |
|
Scientific Title of Study
|
Pharmaceutico-clinical study of Siddarthaka Yoga Taila and ointment and their efficacy in the management of Dadru |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pramod Yadav |
| Designation |
Assistant Professor RSBK |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department Of Rasashastra & Bhaishajya Kalpana, All India Institute Of Ayurveda
Gautam Puri, Sarita Vihar, New Delhi
South
DELHI
110076
India |
| Phone |
|
| Fax |
|
| Email |
drpramod.yadav@aiia.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Yadav |
| Designation |
Assistant Professor RSBK |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department Of Rasashastra & Bhaishajya Kalpana, All India Institute Of Ayurveda
Gautam Puri, Sarita Vihar, New Delhi
DELHI
110076
India |
| Phone |
|
| Fax |
|
| Email |
drpramod.yadav@aiia.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Smrutimayee Sahoo |
| Designation |
PG Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department Of Rasashastra, All India Institute Of Ayurveda,
Gautam Puri, Sarita Vihar, New Delhi
Gautam Puri, Sarita Vihar, New Delhi
South
DELHI
110076
India |
| Phone |
|
| Fax |
|
| Email |
smrutisahoo890@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Gautam Puri, Sarita Vihar, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
All India Institute of Ayurveda, Gautam Puri, Sarita Vihar, New Delhi |
| 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 Pramod Yadav |
All India Institute of Ayurveda New Delhi |
OPD and IPD of Dept. of RSBK, All India Institute of Ayurveda, Gautam Puri, Sarita Vihar, New Delhi
South
DELHI |
9990030755
drpramod.yadav@aiia.gov.in |
|
|
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: B359||Dermatophytosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Siddharthaka Kashaya and ointment base |
Patients will be given Siddharthaka Kashaya 20 ml BD after meals and local application of ointment base for 28 days |
| Comparator Agent |
Siddharthaka Kashaya and Siddharthaka Yoga Ointment |
Patients will be given Siddharthaka Kashaya 20 ml BD after meals along with local application of Siddharthaka Yoga Ointment in quantity sufficient for two times a day for 28 days |
| Comparator Agent |
Siddharthaka Kashaya and Siddharthaka Yoga Taila |
Patients will be given Siddharthaka Kashaya 20 ml BD after meals along with local application of Siddharthaka Yoga Taila in quantity for 28 days sufficient for two times a day |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient between the age group of 16 to 60 years.
1. Patients of both genders.
2. Patients having classical clinical features of Dadru Kustha.
3. Positive for fungal dermatophytes(by 10% of KOH,microscopic
examination)
4. Duration of the disease: Chronicity for more than 3 months, recurrent in nature and or not responding to conventional therapy. |
|
| ExclusionCriteria |
| Details |
Patients suffering from Diabetes,Hypertension and other metabolic
disorder,Autoimmune disorder.
1. Pregnant and lactating women.
2. Chronicity more than 5 years.
3. Lesions with secondary infections.
4. Patients taking immunosuppressive medicines. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the size of lesion, Number of Pidikas accounted and observed,Reduction in the frequency of Kandu, Reduction in the redness of the lesions, Photomicrographs taken before and after treatment in selective cases. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence of signs and symptoms |
14 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
02/05/2020 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
yet to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Clinical study: Setting: Patients suffering from Dadru, will be selected from O.P.D. of All India Institute of Ayurveda, Sarita Vihar, New Delhi – 110076. i
i. Inclusion Criteria: • Patient between the age group of 16 to 60 years. • Patients of both genders. • Patients having classical clinical features of Dadru Kustha. • Positive for fungal dermatophytes(by 10% of KOH,microscopic examination) • Duration of the disease: Chronicity for more than 3 months, recurrent in nature and or not responding to conventional therapy.
iii. Exclusion Criteria: • Patients suffering from Diabetes,Hypertension and other metabolic disorder,Autoimmune disorder. • Pregnant and lactating women. • Chronicity more than 5 years. • Lesions with secondary infections. • Patients taking immunosuppressive medicines.
iii. Method of Data Collection: The data of the selected patients (those who comply with the inclusion criteria) will be enrolled. The selected patients shall undergo the series of events before the treatment, which include Informed Consent on the study, their demographic details and a detailed history.
iv. Grouping : 60 patients will be randomly assigned in three groups
Group 1 – Patient will be given orally Siddharthaka Kashaya (20 ml twice a day before meals) along with local application of Siddharthaka Yoga Taila (Quantity Sufficient).
Group 2 - Patient will be given orally Siddharthaka Kashaya (20 ml twice a day before meals) along with local application of Siddharthaka Yoga Ointment (Quantity Sufficient).
Group 3 – Patient will be given orally Siddharthaka Kashaya(20 ml twice a day before meals)along with local application of ointment base.
v. Duration of study: 28 days. Patients would be provided drugs for every 7 days for four weeks. Routine blood investigations (CBC, ESR, BSL, LFT, KFT) will be done , if required.
vi. Assessment Criteria: a. Changes in the size of lesions. b. Number of Pidikas accounted and observed. c. Reduction in the frequency of Kandu. d. Reduction in the redness of the lesions. e. Photomicrographs taken before and after treatment in selective cases.
Follow Up Follow up will be done on 14th day after the completion of treatment.
i. Parameters of Assessments of Study outcomes:
Overall assessment of the results will be made by considering the collective effect on all the parameters and scoring criteria.
ii. Statistical method for analysis:The parameters of base line data will be compared with the follow up status for assessment of the results.
All the results analysis will be done by using SPSS ver.20 software, and obtained results will be interpreted statistically for ‘p’ value. Repeated measures Anova test |