| 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
|
|
|
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
|
|
|
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: PAMAÂ (KACCU), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | 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
- 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).
- 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsuryanagupta@gmail.com].
- 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.
- 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. |