| CTRI Number |
CTRI/2025/02/079976 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of nirgundi leaves on tinea infection |
|
Scientific Title of Study
|
Standardization of Nirgundi ( Vitex negundo Linn.) and evaluation of its Anti-oxidant activity with special reference to Dadru ( Tinea infection ). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDipti Gaurav Kadam |
| Designation |
Associate Professor |
| Affiliation |
Dr.G.D.Pol Foundations YMT Ayurevd Medical College |
| Address |
Department of Dravyaguna
2nd floor,room no 211, Dr G D Pol Foundations YMT Ayurvedic College Institutional area Sector 4 Kharghar Navi Mumbai Department of Dravyaguna
2nd floor, room no 211, Dr G D Pol Foundations YMT Ayurvedic College Institutional area Sector 4 Kharghar Navi Mumbai Mumbai MAHARASHTRA 410210 India |
| Phone |
09773794332 |
| Fax |
|
| Email |
drdiptimore@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manoj Kadam |
| Designation |
Professor |
| Affiliation |
Dr.G.D.Pol Foundations YMT Ayurvedic Medical College |
| Address |
Department of Dravyaguna
2nd floor, room no 211, Dr G D Pol Foundations YMT Ayurvedic College Institutional area Sector 4 Kharghar Navi Mumbai Department of Dravyaguna
2nd floor, room no 211, Dr G D Pol Foundations YMT Ayurvedic College Institutional area Sector 4 Kharghar Navi Mumbai Mumbai MAHARASHTRA 410210 India |
| Phone |
8767091736 |
| Fax |
|
| Email |
drmanoj.kadam@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jai Kini |
| Designation |
Director research |
| Affiliation |
Dr.G.D.Pol Foundations YMT Ayurvedic Medical College Kharghar |
| Address |
3rd floor, room no 305,Dr G D Pol Foundations YMT Ayurvedic Medical College Institutional area Sector 4 Kharghar Navi Mumbai
Mumbai MAHARASHTRA 410210 India |
| Phone |
9869046901 |
| Fax |
|
| Email |
vd.jaikini@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Dipti Gaurav Kadam |
| Address |
Department of Dravyaguna, 2nd floor, room no 211, Dr.G.D.Pol Foundations YMT Ayurvedic Medical College, Kharghar, Navi Mumbai-410210 |
| 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 |
| DrDipti Kadam |
Dr.G.D.Pol Foundations YMT Ayurved Medical College |
Department of Dravyaguna,2nd floor, room no 211. Raigarh MAHARASHTRA |
09773794332
drdiptimore@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| EthicscommitteeYmtAyurvedic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Terbinafin | Tab.Terbinafine 250 mg OD and Terbinafine ointment for local application ( as per the area involved) | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nirgundi, Reference: Gadanigraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with classical lakshanas of Dadru
2.Patients of all varieties of Tinea will be selected without discriminating its area of infection.
3.Both fresh and treated cases of Dadru will be selected. |
|
| ExclusionCriteria |
| Details |
1.Patients suffering with systemic disorders like uncontrolled Diabetes Mellitus,Auto-Immune diseases, HIV (Clinically diagnosed) will be excluded.
2.Tinea associated with other skin diseases will be exclud.
3.Pregnant and Lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| treatment of fungal infection |
baseline, 7days, 14 days,21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Detailed & Scientific study of Nirgundi Vitex negundo Linn |
baseline, 7days, 14 days,21 days |
|
|
Target Sample Size
|
Total Sample Size="122" Sample Size from India="122"
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)
|
19/02/2025 |
| 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="0" Months="3" 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
|
Tinea or ringworm is one of the most common skin disorders encountered in the clinical practice. It is a group name for a highly contagious segmented Mycelial fungus. It is a commonest single fungus group of infections found in an unhygienic conditions especially in tropical and subtropical countries, unless properly treated they become chronic. It is also prevalently seen in slum areas of Mumbai like Dharavi, Mankhurd. It affects about 35% of the population , it is equally common in men and women 1. It occurs at any age except Tinea capitis which occurs in children mainly. The modern treatment available for Tinea fungal infection gives only symptomatic relief without breaking the pathology and also gives unnecessary side effects to the patients. Dadru is one of the commonly occurring skin diseases which have been included under Mahakushta by Acharya Sushruta2. According to Acharya Dalhana, Dadru is of 2 types, Sitha and Asitha. Dadru Kushta is considered as one of the AsthaMahagada 3. Acharya Charaka has mentioned 18 types of Kusta which are further divided into Mahakushta and Shudrakushta. Dadru has been considered under Shudrakushta by Acharya Charaka. Dadru bears greater resemblance with Tinea. There are different treatment modalities which can be applied, as per the requirement of the situation. That is to say some skin conditions needs shodhana, some needs only shamana, some requires repeated shodhana, raktamokshana etc..,Dadru/Tinea is a condition again where all the treatment modalities can be applied. Nirgundi(Vitex negundo Linn.) has been described by various Acharya, Nighantu grantha as well as Modern Ayurvedic texts.In the text of Gadanigraha,Acharya Shodhal has mentionedNirgundi ( Vitex negundo Linn) patra swarasa lepa reduces Dadru 4. It is used as Kusthaghna, Krimighna dravya in various skin disorders. Dadru is basically Kaphapitta Pradhan vyadhi. Nirgundi (Vitex negundo Linn.) is said to be Jantuhara and Kaphagna, which plays major role in Tinea infection (Dadru). It can be assumed that Nirgundi (Vitex negundo Linn.) by its Anti-oxidant property will reduce oxidative stress in tinea fungal infection patients. Kusthaghna, Krimighanaand kaphaghana effect of Nirgundi (Vitex negundo Linn.) can improve the skin condition of patients of Tinea infection by decreasing symptoms, normalizing skin and avoiding drug dependence and adverse effect. To anticipate the effective management of Dadru vis-Ã -vis Tinea, the present study is undertaken to evaluate the effect of Nirgundi (Vitex negundo Linn.) in the management of Dadru (Tinea infection). |