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CTRI Number  CTRI/2024/07/071244 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 08/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of grihadhoomadi ointment and dineshavalyadi taila in superficial fungal dermatophytosis in children. 
Scientific Title of Study   Randomized comparative clinical study to evaluate the efficacy of grihadhoomadi ointment and dineshavalyadi taila in pama with special reference to superficial fungal dermatophytosis in children. 
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 Suryana Gupta 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital 
Address  Department of PG studies in Kaumabhritya, Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura Main Road Udayapura Post, Bengaluru, Karnataka. India. Pin-560082
21st KM Kanakapura Main Road Udayapura Post, Bengaluru, Karnataka. India. Pin-560082
Bangalore
KARNATAKA
560082
India 
Phone  08825099050  
Fax    
Email  drsuryanagupta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suryana Gupta 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital 
Address  Department of PG studies in Kaumabhritya, Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura Main Road Udayapura Post, Bengaluru, Karnataka. India. Pin-560082
21st KM Kanakapura Main Road Udayapura Post, Bengaluru, Karnataka. India. Pin-560082
Bangalore
KARNATAKA
560082
India 
Phone  08825099050  
Fax    
Email  drsuryanagupta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Divyasri RA 
Designation  Professor, Department of PG studies in Kaumabhritya 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital 
Address  Department of PG studies in Kaumabhritya, Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura Main Road Udayapura Post, Bengaluru, Karnataka. India. Pin-560082
21st KM Kanakapura Main Road Udayapura Post, Bengaluru, Karnataka. India. Pin-560082
Bangalore
KARNATAKA
560082
India 
Phone  9448939421  
Fax    
Email  divya_mesha@yahoo.co.in  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research Hospital. Udayapura P.O., 21 KM, Kanakapura Road, Bangalore, Karnataka 560082 India. 
 
Primary Sponsor  
Name  Dr Suryana Gupta 
Address  Sri Sri College of Ayurvedic Science and Research Hospital 21st KM, Kanakapura main road, Udayapura post, Bengaluru 560082 Karnataka, 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 Suryana Gupta  Sri Sri Ayurveda Hospital  Room No. 309, Department of PG studies in Kaumabhritya, Sri Sri College of Ayurvedic Science and Research 21st KM Kanakapura Main Road Udayapura Post, Bengaluru, Karnataka. India. Pin-560082
Bangalore
KARNATAKA 
08825099050

drsuryanagupta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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: PAMA (KACCU),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-External Application (Procedure Reference: Reddy K. Rama Chandra. Bhaisajya Kalpana Vijnanam, Procedure details: Instructions will be given to the parents regarding the procedure of external application of both Grihadhoomadi Ointment and Dineshavalyadi Taila at home. Parents will be asked to wash the area with lukewarm water, pat dry and apply Grihadhoomadi Ointment/Dineshavalyadi Taila over the affected areas with the help of a sterile cotton and keep it till it gets absorbed into the skin- approx. 45 mins. Route of Administration: External Application Time of Administration - Twice Daily(Morning and Night) Duration of Treatment- 14 Days Duration of Study - 21 Days )
(1) Medicine Name: Grihadhoomadi Ointment, Reference: Chakradatta, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: bd, Duration: 14 Days
(2) Medicine Name: Dineshavalyadi Taila , Reference: Arogya raksha kalpa druma, Route: Topical, Dosage Form: Taila, Dose: 1(ml), Frequency: bd, Duration: 14 Days
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  -Children in between the age group of 5 years to 10 years irrespective of religion, gender, and socio-economic status.
-Children having the clinical features of Pama.
-Children having the clinical features of Superficial Fungal Dermatophytosis.
-Children whose parents are willing to sign the written consent form and follow the protocol.
 
 
ExclusionCriteria 
Details  -Chronic Superficial Fungal Dermatophytosis (more than 1 year duration).
-Superficial Fungal Dermatophytosis associated with secondary infection and lichenification.
-Children presenting with Invasive Fungal Dermatophytosis like Aspergillosis, Invasive Candidiasis, etc.
-Children presenting with other infectious skin diseases like Leprosy, Skin Tuberculosis, etc.
-Other overlapping dermatological diseases like Atopic Dermatitis, Psoriasis, Scabies.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant decrease in Superficial Fungal Dermatophytosis and Pama assessed based on Dermatophytosis Severity Score and Pama Lakshanas respectively.
 
0th day - Before treatment
14th day - after treatment
21st day - follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Generation of in- depth analysed data on different aspects of the disease.
Generation of data on possible unexpected drug reaction. 
0th day - Before treatment
14th day - after treatment
21st day - follow up 
 
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)   01/08/2024 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsuryanagupta@gmail.com].

  6. For how long will this data be available start date provided 18-10-2025 and end date provided 18-06-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Protecting and improving the health of children is of fundamental importance. One of the major illnesses in children are diseases related to the skin, skin being thin, tender, more delicate and easily susceptible to infections, it can range from mild and self- limiting conditions to more serious and chronic disorders affecting mind and other systems of the body. Living with a visible skin condition affects a child’s social and mental wellbeing, in turn affecting his/her growth in all dimensions. One of the common emerging skin disorders in children is Superficial Fungal Dermatophytosis. The prevalence of superficial fungal dermatophytosis has been increasingly growing at a rapid rate over the past few decades in industrialized and developing countries including India especially in younger children due to predisposing factors like warm, humid climate, crowded living conditions, hygiene and poor nutrition. This is probably due to the result of increase in number of immunocompromised children and sedentary lifestyle. 

In Ayurveda skin diseases are explained under the heading of Kushta, Kshudra Rogas, Visarpa, etc. and Pama is a skin disease classified under Kshudra Kushta. It is Kapha Pitta predominant and is characterized by Sweta, Aruna, Syava Pitikas, Srava, Kandu, Toda and Daha. 

Hence, based on the signs & symptoms, Superficial Fungal Dermatophytosis is analogous to Pama which occur in mild, moderate and aggravated forms.

The treatment modality for superficial fungal dermatophytosis comprises of topical application of antifungal ointments, creams, and lotions; topical steroid applications, anti-histamines and moisturizers, which makes skin sensitive on regular usage and leads to flaring up of symptoms on discontinuation of treatment. Taking antifungal medicines for an extended period or failing to complete the prescribed treatment may lead to antifungal resistance making them even more difficult to treat.

Since Pama is Kapha-Pitta Pradhana Vyadhi, Chikitsa should be basically aimed at Sthanika Nirharana of Dushta Kapha and Pitta to alleviate Pidakas, Kandu etc. Very few formulations with such properties are mentioned in the classics for the treatment of Pama, some of them being evaluated for their efficacy, but the efficacy of Pamahara Yogas with special reference to superficial fungal dermatophytosis in children are never attempted so far. As such very few Ayurvedic antifungal creams are available in the market which are proven to be safe and effective with respect to childhood Dermatophytosis. The current study is the first of its kind to evaluate the efficacy and safety of Ayurvedic Pamahara Yogas mentioned in Balarogaadhikara for their antifungal activity in children.

The study aims at providing cost-effective remedy in management of Pama Kushta in children with negligible side-effects and low recurrence rate and hence, here arises the importance of unique formulations like Grihadhoomadi Ointment and Dineshavalyadi Taila where all the drugs are Kaphapittahara and Pamahara possessing Antibacterial, Anti-inflammatory, Anti-allergic and Antimicrobial Activities. Hence, this study is an attempt to evaluate the efficacy of GRIHADHOOMADI OINTMENT and DINESHAVALYADI TAILA in the management of Pama with special reference to Superficial Fungal Dermatophytosis in children.

 
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