FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072593 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 14/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Patients of Dadru(Ring worm) Caused by Tinea Infection & its Treatment With Laghu Manjistadi Kwatha Ghana Vati & Durvadi Lepa, an Ayurvedic Formulation.  
Scientific Title of Study   A Clinical Study of Dadru WSR to Tinea Corporis & its Management with Laghu Manjistadi Kwatha Ghana Vati & Durvadi Lepa 
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 Harish Chandra Giri 
Designation  Assistant professor 
Affiliation  Sri Sri College of ayurvedic science and research hospital 
Address  Department of Roganidan, Sri Sri College of Ayurvedic Science and Research Hospital, Ward no,3 Vidyadharpur, cuttack Cuttack ORISSA 754006 India

Cuttack
ORISSA
754006
India 
Phone  6370925058  
Fax    
Email  harishgirimdnidana68@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harish Chandra Giri 
Designation  Assistant professor 
Affiliation  Sri Sri College of ayurvedic science and research hospital 
Address  Department of Roganidan, Sri Sri College of Ayurvedic Science and Research Hospital, Ward no,3 Vidyadharpur, cuttack Cuttack ORISSA 754006 India

Cuttack
ORISSA
754006
India 
Phone  6370925058  
Fax    
Email  harishgirimdnidana68@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Harish Chandra Giri 
Designation  Assistant professor 
Affiliation  Sri Sri College of ayurvedic science and research hospital 
Address  Department of Roganidan, Sri Sri College of Ayurvedic Science and Research Hospital, Ward no,3 Vidyadharpur, cuttack Cuttack ORISSA 754006 India


ORISSA
754006
India 
Phone  6370925058  
Fax    
Email  harishgirimdnidana68@gmail.com  
 
Source of Monetary or Material Support  
self funded, Sri Sri college of Ayurvedic Science adn Research Hospital, Cuttack, Odisha 
 
Primary Sponsor  
Name  Dr Harish Chandra Giri 
Address  Department of Roganidan, Sri Sri College of Ayurvedic Science and Research Hospital, Ward no,3 Vidyadharpur, cuttack Cuttack ORISSA 754006 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NIl 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harish Chandra Giri   Sri Sri College of Ayurvedic science and research hospital   Department of Roganidana, room no D 212,
Cuttack
ORISSA 		 6370925058

harishgirimdnidana68@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
sri sri college of ayurvedic science and reserch hospital sri sri university INSTITUTIONAL ETHICS COMITTE for biomedical research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:3||Administration. Ayurveda Condition: DADRU-KUSHTHAH, (2) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: DADRU-KUSHTHAH, (3) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-lepa, लेप (Procedure Reference: Sarangadhara, Uttara Khanda, 11th chapter, Procedure details: local application mixed with lemon juice externally until it gets dry automatically, after that rinse with normal water, twice daily)
(1) Medicine Name: Durvadi Lepa, Reference: Chakradutta, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Duration: 30 Days
2Intervention ArmDrugClassical(1) Medicine Name: laghumanjisthadi ghana vati, Reference: bhavaprakash, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -USNA JALA), Additional Information: -
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Classical signs and symptoms of Dadru
Tinea corporis
 
 
ExclusionCriteria 
Details  Patients with systemic disorder like Hypertension, Diabetes mallitus, Leprosy, any carcinogenic disorder, HIV Positive, TB skin, Eczema etc.
Other types of Tinea infection except Tinea Corporis.
Taking immune suppressive medicines
Who have undergoes recent surgeries.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
laghu manjistadi ghana vati is effective in compare with durvadi lepa for treating Dadru kustha (Tinea corporis)  4 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
Durvadi lepa is effective as compared with laghu manjisthadi ghana vati for treatment in dadru kustha(Tinea corporis)  4 week 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/10/2024 
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="3"
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  
•To evaluate the clinical effect  of Laghu Manjisthadi Kwatha Ghana Vati and Durvadi lepa on  Dadru vis - a - vis Tinea corporis.

SOURCE OF PATIENTS:

  Patients will be selected randomly in multi phase from OPD and IPD of Sri Sri College of Ayurvedic Science and Reserch Hospital,Cuttack

STUDY DESIGN :

  30 no of Dadru patients will be taken for the present study and asses the comparision before study and after study.

•

A Special performa will be prepared which includes all data of the patients.

DIAGNOSTIC CRITERIA

The Diagnostic criteria of Dadru is

•Kandu(Itching)
• Raga(Redness)
•Pidaka(Eruption)
•Daha(Burning sensation)
•Rukshyata(Dryness)
•Udgata mandala(Elevation)
•

SUBJECTIVE PARAMETRE:

•Erythma
•Scaly plaqe with raised edges
•Enlarged  raised red central area of clearing
•Itching
•Burning sensasation

OBJECTIVE PARAMETRE:

•DC,TLC,ESR,FBS
•IgE
•Urine –RE and ME
•
•

Laghu Manjistadi Kwatha Ghana Vati : (Bhabaprakash)

•A herbal formulation in Bhaba prakash  part 2 chapter 84 sloka no 99 and 100 taken in to concideration for clinical study.
•Composition:
•Manjistha,Haritaki,Bibhitaki,Amalaki,Katuki,Vacha,Devdaru,Haridra,Nimba twak.
•

Durvadi Lepa

(Chakradatta)

• Drugs and Quantity
• Durva  Cynodon dactylon panchang 1 Part
•Chakramarda  Cassia tora Beeja (seed) 1 Part
• Tulasi Ocimum Sanctum Patra (leaf) 1 Part
• Haritaki Terminalia chebula Phala( fruit) 1 Part
•Saindhav lavana Rock Salt (English name) Lavan(Salt) 1 Part
• Kanji & Takra As requiredfor Bhavana.

The subjective and objective parameters of baseline data pre

and post medication will be compared with gradation for assessment of results. All the results will be analyzed statistically and calculated for signification using paired and unpaired‘t’ test.

 


 
Close