| CTRI Number |
CTRI/2024/12/078623 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of fungal infections through Ayurvedic medications. |
|
Scientific Title of Study
|
Comparative clinical evaluation of Dadruvidravana Malahara with or without Laghu Manjisthadi Kwath Churna in the management of Dadru Kustha (cutaneous dermatophytosis) |
| 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 Itishree Bandana Rth |
| Designation |
PhD scholar |
| Affiliation |
Central Ayurveda Research Institute |
| Address |
c/o- Dr Banamali Das, RO, room no. 4 Central Ayurveda Research Institute, Bharatpur, Bhubaneswar
c/o- Dr Banamali Das, RO, room no. 4 CARI , Bharatpur, Bhubaneswar, Odisha, Pin- 751003
Khordha
ORISSA
751003
India |
| Phone |
8249599454 |
| Fax |
|
| Email |
bandanarath.puri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Banamali Das |
| Designation |
Research Officer |
| Affiliation |
Central Ayurveda Research Institute, Bhubaneswar |
| Address |
O/O-Dr. B.Das,RO,CARI, room no.4 Bharatpur, Near Kalinga Studio, Bhubaneswar,
room no.4, CARI, Bharatpur, Near Kalinga Studio, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9439956684 |
| Fax |
|
| Email |
banamali.d@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Itishree Bandana Rath |
| Designation |
PhD Scholar |
| Affiliation |
Central Ayurveda Research Institute, Bhubaneswar |
| Address |
Room no.4, c/o- Dr B Das, RO
Central Ayurveda Research Institute, Bhubaneswar
Room no.4, c/o- Dr B Das, RO
Central Ayurveda Research Institute, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
8249599454 |
| Fax |
|
| Email |
bandanarath.puri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Ayurveda Research Institute
Bharatpur, Bhubaneswar, Odisha, INDIA 751003 |
|
|
Primary Sponsor
|
| Name |
Central Ayurveda Research Institute |
| Address |
Bharatpur, Near Kalinga studio, Bhubaneswar, Odisha, PIN-751003 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Banamali Das |
Central Ayurveda Research Institute hospital |
Bharatpur, Near Kalinga Studio, Bhubaneswar, Pin-751003
Khordha
ORISSA |
9439956684
banamali.d@gmail.com |
| Dr Itishree Bandana Rath |
KATS Govt. Ayurveda College and Hospital |
O/O- Dy. Superintendent, KATS Govt. Ayurveda College and Hospital, Ankushpur, Pin- 761100
Ganjam
ORISSA |
8249599454
bandanarath.puri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL 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: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Laghu Manjisthadi Kwath , Reference: AFI, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -WATER), Additional Information: FRESH KASHAYA WILL BE PREPARED OUT OF KWATH CHOORNA ON DAILY BASIS FOR USE | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dadruvidraavana Malahar, Reference: AFI, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: LOCAL APPLICATION OF MALAHARA ON AFFECTED PART AS PER REQUIREMENT |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1- Patients with age group between 21 – 60 years of age.
2-Patients irrespective of gender, socio-economic and marital status.
3. Patients willing to participate in the study for a minimum period of 4 weeks.
|
|
| ExclusionCriteria |
| Details |
1. Patients below 21 and above 60 years of age.
2. Patients associated with other type of Kustha.
3. Patients presenting with Dadru Kustha suffering with any other systemic disorders.
4. Lesions with secondary infections.
5. Patients with severe renal or hepatic dysfunction.
6. Patients with Uncontrolled Diabetes Mellitus.
7. Patients taking immunosuppressive medicines.
8. Pregnant women and lactating mother.
|
|
|
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 |
| Assessment will be done on both subjective and objective criteria of Dadru Kustha before & after the intervention |
Assessment will be done on baseline, after 15 days and after 30days on completion of the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of Dadru vidravana malahara on Dadru kustha with or without Laghu Manjisthadi Kwath in the management of Dadru kustha |
Assessment of the effectiveness of Dadru vidravana malahara & Laghu Manjisthadi Kwath in Dadru will be assessed on baseline, after 15days & after 30days of treatment |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="0"
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
|
Title of the study: COMPARATIVE CLINICAL EVALUATION OF DADRUVIDRAAVANA MALAHARA WITH OR WITHOUT LAGHU MANJISTHAADI KWATHA CHURNA IN THE MANAGEMENT OF DADRU KUSTHA (CUTANEOUS DERMATOPHYTOSIS). It is a randomised comparative clinical study which will be conducted with 100 diagnosed cases of Dadru kustha (cutaneous Dermatophytosis) for 30 days. Routine investigations like Hb%, DC, TLC, RBS, HbA1C (if required), LFT, and RFT need to be done to exclude the other systemic disorders. Microscopic examination of 10% potassium hydroxide (KOH) wet-mount preparations of skin scrapings from the active border of the lesions. Patients age ranging from 21 to 60 years will be included in the study. The trial drug Laghu manjisthadi kwath will be given orally at a dose of 48 ml twice daily for a period of 30 days with the external application of Dadruvidravana malahara. The detailed clinical record will be kept in a specified CRF before the initiation of treatment. Prior informed written consent will be taken from the patient to be included in the trial. the follow up and improvements will be recorded in the CRF on 15th day, the 30th day of treatment and 2weeks after completion of treatment. Any adverse reaction during the treatment will be reported to the Pharmacovigilance cell of CCRAS and rescue medication will be applicable as per institution norms. Ethical approval-The study has received IEC approval to be carried out. |