| CTRI Number |
CTRI/2026/04/107515 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
02/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to compare the effectiveness of two Ayurvedic Medicines Patola triphaladi Kashaya and Amrtavrishadi Kashaya in Urticaria |
|
Scientific Title of Study
|
A Comparative Clinical Trial to evaluate the effectiveness of Patola triphaladi Kashaya in comparison to Amrtavrishadi Kashaya in Urticaria |
| 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 JEEVAN K G |
| Designation |
Research Scholar (PhD) |
| Affiliation |
Glocal College of Ayurvedic Medical Science and Research Centre |
| Address |
GLOCAL UNIVERSITY
MIRZAPUR, SAHARANPUR, UTTARPRADESH,INDIA
Saharanpur
UTTAR PRADESH
247121
India |
| Phone |
9961993323 |
| Fax |
|
| Email |
jeevanjeevanss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JEEVAN K G |
| Designation |
Research Scholar (PhD) |
| Affiliation |
Glocal College of Ayurvedic Medical Science and Research Centre |
| Address |
GLOCAL UNIVERSITY
MIRZAPUR, SAHARANPUR, UTTARPRADESH,INDIA
Saharanpur
UTTAR PRADESH
247121
India |
| Phone |
9961993323 |
| Fax |
|
| Email |
jeevanjeevanss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N VIMALA |
| Designation |
Professor |
| Affiliation |
Glocal College of Ayurvedic Medical Science and Research Centre |
| Address |
GLOCAL UNIVERSITY
MIRZAPUR, SAHARANPUR, UTTARPRADESH,INDIA
Saharanpur
UTTAR PRADESH
247121
India |
| Phone |
9447006465 |
| Fax |
|
| Email |
drnvimalaajith@gmail.com |
|
|
Source of Monetary or Material Support
|
| GLOCAL UNIVERSITY
MIRZAPUR, SAHARANPUR, UTTARPRADESH, 247121, INDIA
|
| GOVERNMENT AYURVEDA HOSPITAL OTTAPALAM,PALAKKAD, KERALA,679104 |
|
|
Primary Sponsor
|
| Name |
Dr JEEVAN K G |
| Address |
PhD Scholar, GLOCAL UNIVERSITY
MIRZAPUR, SAHARANPUR, UTTARPRADESH, 247121, INDIA
|
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr JEEVAN K G |
Glocal College of Ayurvedic Medical Science and Research Centre |
GLOCAL UNIVERSITY
MIRZAPUR, SAHARANPUR, UTTARPRADESH, 247121, INDIA
Saharanpur
UTTAR PRADESH |
9961993323
jeevanjeevanss@gmail.com |
| Dr JEEVAN K G |
Government Ayurveda Hospital Ottapalam |
Government Ayurveda Hospital Ottapalam, Palakkad,Kerala 679104
Palakkad
KERALA |
9961993323
jeevanjeevanss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Glocal University Institutional Ethics Committee |
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: Patola Triphaladi kashaya, Reference: Sahasrayoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amrtavrishadi Kashaya, Reference: Sahasrayoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with signs and symptoms of Urticaria
Both male and female participants between the age group of 18-70 presenting with less than 50 wheals along with and symptoms such as itching, rashes, dermatographism |
|
| ExclusionCriteria |
| Details |
Participants on continuous allopathic medications for urticaria
Participants having history of anaphylaxis and urticarial vasculitis
Participants having drug allergy
Participants with uncontrolled systemic illness
Patients not co-operating with the study
Pregnant women and lactating mothers
Others dermatological conditions like contact dermatitis, allergic eczema, angioedema |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in severity of urticaria symptoms (itching, wheals,rashes,dermatographism)using a predefined symptom grading scale |
from baseline to day 15, day 30, day 45 and day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in Urticaria Activity score |
during baseline (Day 1-7), during treatment (Day 39 -45), and end of study (Day 53 -59) |
| Change in serum IgE levels |
from Baseline (Day 0) to day 60 |
|
|
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 2 |
|
Date of First Enrollment (India)
|
15/04/2026 |
| 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
|
Urticaria is a common dermatological condition characterized by wheals, itching, and erythema. This study aims to evaluate the effectiveness of Patola triphaladi Kashaya compared to Amrtavrishadi Kashaya in managing urticaria. A total of 122 participants will be randomized into two groups and treated for 45 days with a follow-up of 15 days. Outcomes will be assessed using symptom grading scale, Urticaria Activity Score (UAS7), and serum IgE levels |