| CTRI Number |
CTRI/2024/07/070503 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Nava Kashaya Ghana Vati with Prapunnatadi Lepa in relieving signs and symptoms in patients of Dadru Kushta (Tinea Corporis) |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to Evaluate the Efficacy of Nava Kashaya Ghana Vati with Prapunnatadi Lepa and Triphaladi Gutika with Aragwadha Lepa in the Management of Dadru Kushta with special reference to Tinea Corporis |
| 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 Shashikala Hanamant Antartani |
| Designation |
PG SCHOLAR KAYACHIKITSA |
| Affiliation |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot
Bagalkot Karnataka 587 101 india
Bagalkot
KARNATAKA
587101
India |
| Phone |
9632630782 |
| Fax |
|
| Email |
shashih058@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunilkumar M Chabanur |
| Designation |
HOD and Associate Professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot
Bagalkot Karnataka 587 101 india
Bagalkot
KARNATAKA
587101
India |
| Phone |
9740878703 |
| Fax |
|
| Email |
drsunilkumar09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunilkumar M Chabanur |
| Designation |
HOD and Associate Professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot
Bagalkot Karnataka 587 101 india
KARNATAKA
587101
India |
| Phone |
9740878703 |
| Fax |
|
| Email |
drsunilkumar09@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVVS Ayurved Medical College and Hospital Bagalkot Karnataka 587 101 |
|
|
Primary Sponsor
|
| Name |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot, Karnataka 587 101 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shashikala Hanamant Antartani |
BVVS Ayurved Medical college and Hospital, Bagalkot |
department of Kayachikitsa, kayachikitsa OPD, room number 1.
Bagalkot
KARNATAKA |
9632630782
shashih058@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECBVVSAyurvedMedicalCollegeandHospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B354||Tinea corporis. Ayurveda Condition: DADRU-KUSHTHAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: nava kashaya ghana vati, Reference: vangasena samhita kushtarogadhikara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -sukhoshna jala), Additional Information: -(2) Medicine Name: prapunnatadi lepa, Reference: basavarajeeyam kushtarogadhikara, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: triphaladi gutika, Reference: vangasena samhita kushtarogadhikara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -sukhoshna jala), Additional Information: -(2) Medicine Name: aragwadha lepa, Reference: vangasena samhita kushtarogadhikara, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of Dadru Kushta
Patients with the age group between 18-60 years of either sex |
|
| ExclusionCriteria |
| Details |
Patients associated with other types of Kushta
Systemic disorders like uncontrolled DM, HTN and autoimmune diseases which interfere with the course of the treatment
Tinea corporis associated with other types of tinea infection and other skin diseases
Pregnancy and Lactation |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess subjective and objective parameters Itching, Erythema, Burning sensation, Pustule / vesicle, Dryness, Circular elevated lesions, size of lesions and number of lesions |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess subjective & objective parameters, Itching, Erythema, Burning sensation, Pustule / vesicle, Dryness, Circular elevated lesions, size of lesions & number of lesions |
10th 20th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
20/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In Ayurveda science, all the skin diseases are classified under the broad heading of Kushta. Due to Nidana Sevana, there is a simultaneous vitiation of Tridoshas and Shaithilyata in the Dhathus such as Twak, Asrik, Mamsa and Lasika which leads to the manifestation of the disease Kushta, which are further divided into Maha Kushta and Kshudra Kushta. Dadru Kushta is one among the Kshudra Kushta, where Rasa, Rakta and Mamsa Dhatus are involved, and it is mainly of Kapha Pitta Pradhana Twak Vikara.It is characterized by Kandu, Raga, Pidaka, Daha and Utsanna Mandala. Based on the similar Clinical features, Dadru Kushta may be closely compared with Tinea Corporis which considered under the superficial fungal infection of the skin.
Tinea corporis is the ringworm infection of the glabrous skin (Hairless skin of the body) and it includes lesions of the trunk and limbs excluding specialized sites such as the scalp, feet and groins. The Prevalence of Tinea infection is ~2% among young adults and upto 20% among individuals 40-60 years of age. 30% of worldwide population is suffering from Tinea. In India also 5 out of 1000 people are suffering from Tinea Infection.
In Modern medicine, Tinea is treated with oral antifungal, topical medications, and steroids. But there are limitations for these drugs for the longer usage because of adverse effects. In Ayurveda Shodhana, Shamana and Bahirparimarjana Chikitsa has been explained for Dadru Kushta. Nava Kashaya mentioned in Vangasena Samhita Kushta rogadhikara,which prepared in the form of Ghana Vati having ingredients Triphala does the Agni Deepana and Tridoshahara karma. Nimba, Rohini, Rajani, Patola and Vacha are collectively possesses Kapha Pitta Shamaka property and Kushtaghna, Kandughna, Krimighna in action. Manjishta act as Rakta Shodhaka. Prapunnatadi Lepa mentioned in Basavarajeeyam Kushta Rogadhikara having ingredients Prapunnata Beeja does Kaphahara Karma and Kandughna due to its Ushna Virya. Nisha, Nimba Patra, Abhaya and Snuhi Patra are collectively does Kapha Pitta Shamana and possesses Kandughna, Kushtaghna, Krimighna property. Triphaladi Gutika mentioned in Vangasena Samhita Kushta Rogadhikara is indicated in Dadru Kushta. It is having ingredients mainly Triphala, Arushkara, Avalguja, Bhringaraja, Loha, Langali, Varahi Kanda, Trikatu are collectively having Ushna Virya and Katu Vipaka. So, over all these drugs are Deepana, Pachana, Kapha Pittahara, Kandughna, Krimighna and Kushtaghna in action. Aragwadha Lepa mentioned in Vangasena Samhita Kushta Rogadhikara is indicated in Dadru Kushta. It contains the main ingredient Aragwadha Patra having Madhura Rasa, Sheeta Virya and Madhura Vipaka act as Pittahara and controls Daha, Raga Lakshanas in Dadru Kushta. It has Rakta Shodhaka property, and it is indicated as a Bahya Parimarjana due to its Pitta Shamaka action.
Hence the present study aims to evaluate the efficacy of Nava Kashaya Ghana Vati with Prapunnatadi Lepa and Triphaladi Gutika with Aragwadha Lepa in Dadru Kushta with special reference to Tinea Corporis.
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