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CTRI Number  CTRI/2024/08/072546 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 13/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   TO EVALUATE THE EFFECT OF PATOLAKHADIRADI KASHAYA IN THE MANAGEMENT OF SKIN INFECTION. 
Scientific Title of Study   A RANDOMIZED CONTROLLED TRIAL ON THE EFFECT OF PATOLAKHADIRADI KASHAYA IN THE MANAGEMENT OF DADRU KUSHTA (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 Balajapalli Sri Saraswathi 
Designation  Post Graduate Scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai 
Address  Room no 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  9398097762  
Fax    
Email  saraswathi8558@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradeep Kumar Moharana 
Designation  Professor 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Room no 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  9444123608  
Fax    
Email  pkm_ayur@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Balajapalli Sri Saraswathi 
Designation  Post Graduate Scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai 
Address  Room no 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  9398097762  
Fax    
Email  saraswathi8558@gmail.com  
 
Source of Monetary or Material Support  
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet TamiL Nadu 600124 
 
Primary Sponsor  
Name  Dr Balajapalli Sri Saraswathi 
Address  Room no 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Tamil Nadu 600124 
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 Balajapalli Sri Saraswathi  Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai  Room no 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai
Thiruvallur
TAMIL NADU 
9398097762

saraswathi8558@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Sri Jayendra Saraswathi Ayurveda College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B359||Dermatophytosis, unspecified. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Laghu Manjisthadi Kashaya, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Patolakhadiradi Kashaya, Reference: Sahasra Yogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients between age group of 18-70 years
Patients with reddish annular skin lesions with itching
Patients with skin lesions over face trunk scalp groin region hands and legs 
 
ExclusionCriteria 
Details  Patients below 18years and above 70 years
Patients with lesions over mucosa membrane of the body
Patients where they have skin lesions with exudation
Patients with negative fungal culture
Patients on corticosteroid therapy
Pregnant and lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in erythema itching and size of skin lesion  At basline
At 15th day
At 31st day 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Quality of life  15 days 
 
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   Phase 3 
Date of First Enrollment (India)   25/08/2024 
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="1"
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  

Dermatophytes are the most ubiquitous fungal pathogens worldwide responsible for majority of skin, hair and nail infections which belong to the group of organisms that are able to breakdown keratin in tissues. The predisposing factors being tropical climate, humidity, tight clothes, occlusive footwear, sharing personal items with an infected person, poor hygiene. It is presented as annular erythematous lesions with active border, central healing and itching. Dermatophytosis is ranked 6th among the dermatological conditions in Global Burden of Diseases in 2019. Superficial dermatophytosis affects 20-25% of world populations and is a common infective dermatosis in clinical practice. The current reported prevalence in India falls in a very wide range 6.09% - 61.5%. Study conducted by Verma SB et al, stated that there has been an increase in the incidence of dermatophytosis across the country in the past 5–6 years. And there has been a significant increase in the incidence of chronic, relapsing, recurrent cases of superficial dermatophytosis in India that are also often unresponsive to conventional drugs and doses of recommended antifungal treatment. Serious consequences are uncommon; however, the illness may be disfiguring and uncomfortable and spread of fungus is accelerated in hot and humid climate. Work done by Jamil RA et al, showed that quality of life was highly impaired in the patients with dermatophytosis and it also showed a significant association with financial burden. In Ayurvedic classics, the Lakshanas of Dadru are Kandu (itching), Raaga (erythema), Pidika (papules) and Udgata Mandala (raised circular patches), so Dadru can be established parallel to Dermatophytosis. Dadru is one type of Kushta where the vitiated Doshas Pitta and Kapha in turn vitiate Rasa, Rakta, Mamsa, Lasika and presents the Lakshanas over Twak. Treatment should aim at Vyadhivipareeta Chikitsa which helps in Samprapti Vighatana and helps in attaining Samyata of Dosha and Dushya. Patolakhadiradi kashaya has Patola, Khadira, Nimba, Indravaruni, Katurohini and Shunti which are predominantly Tikta, Katu, Kashaya Rasa, Laghu-Rooksha Guna, has Pitta – Kaphahara Karma. So, the formulation has been selected as the trial drug. Therefore, it is hypothesized that Patolakhadiradi Kashaya will be helpful in the breakdown of pathogenesis of this condition. Taking this all into consideration, this study entitled – “A Randomized controlled trial on the effect of Patolakhadiradi Kashaya in the management of Dadru Kushta (Dermatophytosis).” is undertaken.


 
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