| CTRI Number |
CTRI/2024/07/069821 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to see the effect of Suvarnakadi yoga in the management of Fungal infection. |
|
Scientific Title of Study
|
An open clinical study to evaluate efficacy of Suvarnkadi yoga in the management of Dadru with special reference to Tinea Carporis. |
| 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.Snehal Bhagwat Patil |
| Designation |
PG Scholar |
| Affiliation |
R.A.Podar Ayurvedic Hospital Worli Mumbai-18 |
| Address |
R.A.Podar Ayurvedic Hospital near dr.annie besant road Worli Mumbai Pincode-400018 Kayachikitsa Department Ground Floor OPD No.19
Mumbai MAHARASHTRA 400018 India |
| Phone |
9421514742 |
| Fax |
|
| Email |
vd.snehalpatil1995@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Mukund Dinkararao Magare |
| Designation |
Associate Professor |
| Affiliation |
R.A.Podar Ayurvedic Hospital Worli Mumbai-18 |
| Address |
R.A.Podar Ayurvedic Hospital Near, dr. Annie Basant besant road Worli Mumbai Pincode-400018 Kayachikitsa Department,Ground Floor OPD No 19
MAHARASHTRA 400018 India |
| Phone |
9221221169 |
| Fax |
|
| Email |
mukundmagare@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrSnehal Bhagwat Patil |
| Designation |
PG Scholar |
| Affiliation |
R.A.Podar Ayurvedic Hospital Worli Mumbai-18 |
| Address |
R.A.Podar Ayurvedic Hospital Near,dr.Annie Besant Road Worli Mumbai-18 Pincode-400018 at Kayachikitsa Department Ground Floor OPD No 19
MAHARASHTRA 400018 India |
| Phone |
9421514742 |
| Fax |
|
| Email |
vd.snehalpatil1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.A.Podar Ayurvedic Hospital Worli Mumbai-18 |
|
|
Primary Sponsor
|
| Name |
RAPodar Ayurvedic Hospital |
| Address |
R.A.Podar Ayurvedic Hospital worli mumbai-18,Near,dr.Annie Besant Road Worli Mumbai-18, Pin-400018 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MAPodar Ayurvedic Hospital Worli Mumbai |
R.A.Podar Ayurvedic Hospital Worli Mumbai-18,Near, dr.Annie Besant Road Worli Mumbai, Pin-400018 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSnehal Bhagwat Patil |
R.A.Podar Ayurvedic Hospital |
R.A.Podar Ayurvedic Hospital Worli Mumbai-18,near dr.Annie Besant Road Worli Mumbai-18,Pin-400018 Kayachikitsa Department Ground Floor OPD No 19 Mumbai MAHARASHTRA |
9421514742
vd.snehalpatil1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Committee of the institution R.A.Podar ayurvedic medical College worli mumbai |
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: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Suvarnakadi yoga, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: We have selected Suvarnakadi yoga which contains 4 drugs 1 Aaragwadha
2 Chakramarda
3 Guduchi
4 Khadira
Suvarnakadi yoga is swanubhut yog drugs in suvarnakadi yoga are selecthed seperately throgh bhavaprakasha nighantu these all drugs have kushthaghna property |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with sign and symptoms of Dadru like kandu,pidika,vaivarnya and mandala.
Understanding and being willing to sign the informed concent form |
|
| ExclusionCriteria |
| Details |
Patient having skin lesion other than dadru kushtha(Tinea corporis)like eczema,psoriasis,urticaria.
Pregancy and lactating mother.
Immuno-compromised patients like AIDS,HbsAg positive etc.
Person with sever disorder like CA,liver disease,renal or cardiac problems,bed ridden due to chronic illness.
Patient having uncontrolled DM/HTN.
Any complication arising during the treatment of any patient discontinuing tratmrnt will be excluded. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the effect of suvarnakadi yoga in reducing the symptoms of tinea carporis like itching, discolouration,boils and patches |
28 days
Follow up every week at 1st,2nd,3rd,4th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the role of suvarnakadi yoga in reducing itching,boils, discolouration, in dadru(tinea Carporis).
Maximum longitudinal length & horizontal length area will be calculated before & after using butter paper & graph papaer.
To study the formulation of suvarnakadi yoga.
To assess the acceptability & saftey of suvarnakadi yoga.
To study the disease dadru with ayurveda & modern aspect with tinea corporis. |
28 days
Follow up every week at 1st,2nd,3rd,4th 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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 - NO
|
|
Brief Summary
|
Skin is the largest organ of human body. Its size and external location makes it susceptible to a wide variety of disorders. In recent years there has been increase in incidence of skin problem due to various reasons like Poverty, Poor sanitation, Unhygienic condition, Pollution, Diwaswap’, vegavidharana, virudhashana", Stress etc. Skin diseases creates an emotional concern for an individual which includes embarrassment, low self esteem, anxiety, depression and shame.
In Ayurveda the word ’kushtha is broad term which covers almost all skin disorders. Acharya Charaka has described 18 types of kushtha rogas which then classified into 7 types of Mahakushtha and 11 types of Kshudra Kushtha, Dadru’ is among these Kshudra Kushtha while according to Acharya sushruta it is Mahakushtha".
Dadru is a tridoshaj twak vikara with Pitta-Kapha predominance". Acharya Charaka has described Dadru Kushtha under 4 th layer of the Twacha. It involves clinical features like Kandu, Raga, Pidika, Mandala¹
सराग कणà¥à¤¡à¥‚ पिडकं ददà¥à¤°à¥ मणà¥à¤¡à¤²à¤®à¥à¤¦à¥à¤—तमॠ॥ च. चि.à¥/३३।
These symptoms are very much similar with the features of ’Tinea Carporis’ means highly contagious fungal infection spreading all over the body etc. Through modern perspective it comes under the superficial fungal infection of skin caused by the keratinophilic fungi. Tinea Carporis involves body, arms, and legs etc. It is common skin disease in India with prevalence rate of superficial mycotic infection worldwide has been found 20-25%."
Shodhana is very much time consuming process and requires proper samsarjan krama palana (means proper pathya palana) also lepana chikitsa is time consuming. In this modern era people are busy in their schedules so they don’t have time for shodhana and lepa chikitsa and they seek option for that. So there is a need of better shamana chikitsa which acts on rasavaha, raktavaha and mansavaha strotasa". Because Shata Twacha is konwn as Updhatu of Mans dhatu.
For that I have formulated" Suvarnakadi Yoga". In Dadru
kledaghna, Kandughna, kaphaghna, varnyakara, raktashodhniya chikitsa is required and Suvarnakadi yoga contains Aragwadha, Chakramarda, Guduchi, Khadira. Kleda is basic cause for kushtha so for samprapti bhanga main aim of treatment is to reduced kleda. In " Suvarnakadi Yoga" Khadira has kledghna property due to ruksha, laghu, sheet Guna. It has raktashodhana property due to tikta, Kashay rasa Chakramarda has katu rasa, laghu ruksha guna basically acts as kledaghna and kapha-pittashamak. Guduchi has tikta rasa which work on raktavaha strotasa. Yakruta and pilha are moolasthana of raktavaha strotasa". It has yakrit gamitva effect which is important for treatment of Dadru. According to Aacharya Bhavprakasha Aragwadha is sransana drvya which acts on koshtha and helps in samprapti bhanga of dadru kushtha by reducing the kleda in the koshtha.
Taking all above consideration in my mind I have selected this topic.
"AN OPEN CLINICAL STUDY TO EVALUATE EFFICACY OF ’SUVARNAKADI YOGA’ IN THE MANAGEMENT OF DADRU WITH SPECIAL REFERENCE TO TINEA CARPORIS." |