| CTRI Number |
CTRI/2025/09/095267 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
study Champakadi Agada versus Cetirizine in Sheetapitta |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Champakadi Agada versus Cetirizine in Sheetapitta (Recurrent Urticaria)-A reverse pharmacology approach. |
| 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 Priya Raut |
| Designation |
Assistant professor Department of Agadtantra |
| Affiliation |
Datta meghe ayurvedic medical college hospital and research centre wanadongri Hingana Nagpur. |
| Address |
Datta meghe ayurvedic medical college hospital and research center wanadongri,Hingana ,Nagpur.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
07972557960 |
| Fax |
|
| Email |
priyakakde85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRIYA RAUT |
| Designation |
Assistant professor Department of Agadtantra |
| Affiliation |
Datta meghe ayurvedic medical college hospital and research centre wanadongri Hingana Nagpur. |
| Address |
department of Agadtantra ,Datta meghe ayurvedic medical college hospital and research center wanadongri hingana nagpur
Datta meghe ayurvedic medical college hospital and research center wanadongri hingana nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
07972557960 |
| Fax |
|
| Email |
priyakakde85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRIYA RAUT |
| Designation |
Assistant professor |
| Affiliation |
Datta meghe ayurvedic medical college hospital and research centre wanadongri Hingana Nagpur. |
| Address |
Datta meghe ayurvedic medical college hospital and research center wanadongri hingana road Nagpur.
Nagpur
MAHARASHTRA
4400024
India |
| Phone |
07972557960 |
| Fax |
|
| Email |
priyakakde85@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Priya Mohan Raut |
| Address |
Datta meghe ayurvedic medical college hospital and research centre wanadongri hingana Nagpur. |
| 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 Priya Raut |
Mahatma Gandhi Ayurvedic medical college Hospital and research center |
department of Agadtantra,Mahatma Gandhi ayurvedic medical college hospital and research center wanadongri hingana Nagpur.
Nagpur
MAHARASHTRA |
07972557960
priyakakde85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee ,Mahatma gandhi Ayurvedic medical college hospital and research center salod (H), Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L509||Urticaria, unspecified. Ayurveda Condition: SITAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: champakadi agad, Reference: ashtang hridaya uttartantra , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: no | | 2 | Comparator Arm (Non Ayurveda) | | - | cetrizine | antihistamine |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 18-60 years
2. Patients diagnosed with Sheetapitta (recurrent Urticaria) as per Ayurvedic diagnostic criteria
3. Patients with mild to moderate Sheetapitta (Urticaria)
4. Patients with a history of Sheetapitta (Urticaria) for at least 6 weeks
5. Patients of Sheetapitta willing to give consent.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating women
2. Patients with severe Sheetapitta (Urticaria) requiring hospitalization or emergency treatment
3. Patients taking medications that may interact with Champakadi Agad or Cetrizine, such as antihistamines, corticosteroids, or immunosuppressants
4. Patients with known allergies to Champakadi Agada ingredients or Cetrizine
5. Patients with chronic diseases such as diabetes, hypertension, or kidney disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Champakadi Agada will demonstrate significant improvement in reducing Urticaria Activity Score (UAS), reduction in urticarial signs and symptoms compared to Cetrizine at the end of the 6-week treatment period.
2. The optimal dose of Champakadi Agada will be determined, with maximum efficacy at a specific dose and minimal adverse effects.
|
4-5 weeks, followup will be taken on 14 weeks, 30 weeks, 45th day of enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Champakadi Agad may show faster & more significant relief from symptoms such as itching, redness, & swelling compared to Cetrizine.
2. Champakadi Agada may found to be safe & well-tolerated, with fewer adverse effects compared to Cetrizine.
3. In future studies we will be able to find out the phytochemical analysis of Champakadi Agada which revealed the presence of bioactive compounds with anti-inflammatory & anti-allergic properties.
4. The study will be helpful to demonstrate Champakadi Agadas anti-urticarial effects through inhibition of histamine release, reduction of inflammatory cytokines, & modulation of the immune system.
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
05/10/2025 |
| 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="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
|
Champakadi Agada, a traditional Indian herbal formulation, has been widely used to treat insect bites and various skin disorders. This natural remedy combines medicinal herbs with anti-inflammatory, antibacterial, and soothing properties. When applied, Champakadi Agada can effectively alleviate symptoms of skin allergies ,including redness, swelling, and itching. This study explores the traditional use, processing, and potential health benefits of Champakadi Agada as a home remedy for skin allergies. Further research and clinical trials are necessary to validate its efficacy and potentially integrate it into broader dermatological treatments. |