| CTRI Number |
CTRI/2025/11/096895 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| 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
|
Role of Khadirashtaka Kwatha in Skin disease(Urticaria) |
|
Scientific Title of Study
|
An Open-Label Randomized Controlled Clinical Study To Evaluate The Efficacy Of Khadirashtaka Kwatha In The Management Of Chronic Urticaria (Sheetapitta) |
| 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 Disha Jayeshkumar Sakalshawala |
| Designation |
Kayachikitsa PG Scholar |
| Affiliation |
G. J. Patel Institute Of Ayurvedic Studies And Research |
| Address |
Department Of Kayachikitsa, OPD No. 14, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120
Anand
GUJARAT
388120
India |
| Phone |
9265014966 |
| Fax |
|
| Email |
dishajs123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya EA |
| Designation |
Associate Professor of Kayachikitsa |
| Affiliation |
G. J. Patel Institute Of Ayurvedic Studies And Research |
| Address |
Department Of Kayachikitsa, OPD No. 14, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120
Anand
GUJARAT
388120
India |
| Phone |
9847003989 |
| Fax |
|
| Email |
soumya.ea@cvmu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Disha Jayeshkumar Sakalshawala |
| Designation |
Kayachikitsa PG Scholar |
| Affiliation |
G. J. Patel Institute Of Ayurvedic Studies And Research |
| Address |
Department Of Kayachikitsa, OPD No. 14, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120
Anand
GUJARAT
388120
India |
| Phone |
9265014966 |
| Fax |
|
| Email |
dishajs123@gmail.com |
|
|
Source of Monetary or Material Support
|
| S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120 |
|
|
Primary Sponsor
|
| Name |
Dr Disha Jayeshkumar Sakalshawala |
| Address |
Department Of Kayachikitsa, OPD No. 14, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120 |
| 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 Disha Jayeshkumar Sakalshawala |
S. G. Patel Ayurveda Hospital And Maternity Home |
Department Of Kayachikitsa, OPD No. 14, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388121
Anand
GUJARAT |
9265014966
dishajs123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G. J. Patel Institute Of Ayurvedic Studies And Research And S.G.Patel Ayurveda Hospital And Maternity Home Institutional (Human) Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L508||Other urticaria. Ayurveda Condition: SITAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Khadirashtaka Kwatha, Reference: Vangasena Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tablet. Levocetrizine | Medicine Name: Tablet Levocetrizine, Route: Oral, Dosage Form: Tablet, Dose: 5 mg, Frequency: at bedtime, Duration: 4 Weeks, Anupana: water |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who have fulfilling Diagnostic criteria for Sheetapitta and the international
guideline (EAACI/GA2LEN/EDF/WAO) for Chronic Urticaria.x
2. Patients who are willing and able to participate in the study and have
Chronic Urticaria, defined as an urticarial eruption for more than 6 weeks
duration.
3. Both male and female patients are between the age group of 20 – 60 years.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are less than 20 years and more than 60 years in the age group.
2. The disease conditions and medication which will interfere the research output will be
excluded.
3. Urticaria less than 6 weeks duration.
4. Drug induced Urticaria.
5. Pregnant and lactating women.
6. Patients with autoimmune diseases like Psoriasis, SLE.
7. Patients having angioedema.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Khadirashtaka Kwatha on Chronic Urticaria ( Sheetapitta) |
1st, 2nd, 3rd and 4th week. Follow up on 5th and 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve the Quality of life of the patient (QoL) of Chronic Urticaria (Sheetapitta) |
1st week and 6th week |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study adopts an open-label randomized controlled design, enrolling diagnosed cases of chronic urticaria. Participants will be randomly assigned to two groups—one receiving Khadirashtaka Kwatha 48 ml after meals bd with lukewarm water for 4 weeks and the other receiving Tab Levocetirizine 5 mg at bed time once a day with water for 4 weeks. Clinical evaluation will be based on subjective parameters along with objective measures. The follow-up period will be 2 weeks. This study seeks to scientifically validate the efficacy of Khadirashtaka Kwatha in managing Sheetapitta, correlating Ayurvedic principles with modern clinical parameters. If proven effective, this intervention could offer a holistic, safe, and sustainable approach to managing chronic urticaria, supporting the integration of Ayurvedic formulations into evidence-based clinical practice. |