| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B359||Dermatophytosis, unspecified. 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 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: - | | 2 | Intervention Arm | Drug | Classical | | (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. |