| CTRI Number |
CTRI/2025/08/093049 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing the Effectiveness of Kushthadi Agada Ointment for Relief from Insect Bites |
|
Scientific Title of Study
|
Evaluation of the Efficacy of Kushthadi Agada Ointment in the Management of Insect Bite A Single Arm Study
|
| 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 Omprakash Patel |
| Designation |
PG SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
| Address |
Department of Agadtantra and Vidhi Vaidyaka
Mahatma Gandhi Ayurved College Hospital and Research Centre DMIHER Salod Wardha
MAHARASHTRA INDIA
pincode 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
7748904932 |
| Fax |
|
| Email |
om.patel8583@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Chalakh |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
| Address |
Department of Agadtantra and Vidhi Vaidyaka
Mahatma Gandhi Ayurved College Hospital and Research Centre DMIHER Salod Wardha
MAHARASHTRA INDIA
Pincode 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9850366073 |
| Fax |
|
| Email |
sonali.chalakh@dmimsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Chalakh |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
| Address |
Department of Agadtantra and Vidhi Vaidyaka
Mahatma Gandhi Ayurved College Hospital and Research Centre DMIHER Salod Wardha
MAHARASHTRA INDIA
pincode 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9850366073 |
| Fax |
|
| Email |
sonali.chalakh@dmimsu.edu.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre DMIHER Salod Wardha
Maharashtra India PINCODE 442001
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre DMIHER Salod Wardha |
| Address |
Department of Agadtantra and Vidhi Vaidyaka
Mahatma Gandhi Ayurved College Hospital and Research Centre DMIHER Salod Wardha
MAHARASHTRA INDIA
pincode 442001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Omprakash Patel |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha 442001 |
Department of Agadtantra and Vidhi Vaidyaka
Mahatma Gandhi Ayurved College Hospital and Research Centre DMIHER Salod Wardha
MAHARASHTRA INDIA
pincode 442001
Wardha
MAHARASHTRA |
7748904932
om.patel8583@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Centre Institutional Ethics Committee Salod Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: KITAVISHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kushthadi Agada, Reference: Shusrut Samhita, Kalap Sthana, Keetavisha Adhaya, Shlok no. 47, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0(NA), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: DURATION Till 5 days and will extended as per the need of patient
|
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients belonging to both genders.
2. Patient of an insect bite with Symptoms of inflammation and pain
3. Classical Symptoms (Redness, Itching, Burning Sensation, Inflammation, Pain, etc.)
|
|
| ExclusionCriteria |
| Details |
1.Severe Allergic Reactions to Insect Bites
2.Active Skin Infections (bacterial, fungal infections, etc.)
3.Chronic Skin Conditions( psoriasis, eczema etc)
4.Systemic Immune Disorders ( Rheumatoid arthritis, lupus erythematosus, etc.)
5.Recent Use of Immunosuppressive Medications (corticosteroids, etc.)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Kushthadi Agada in relief of the symptoms of insect bite |
5 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Eliminate The Common Symptoms Of Insect Bite Such As Pain, Redness, Inflammation, Itching, Burning Sensation |
5 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/ Phase 4 |
|
Date of First Enrollment (India)
|
12/01/2026 |
| 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="2"
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
|
The volunteers will be informed about the study protocol. Willing participants will be selected. The clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria it will include 15 days treatment and follow up. |