CTRI/2026/03/105855 [Registered on: 10/03/2026] Trial Registered Prospectively
Last Modified On:
25/02/2026
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A Clinical Study Comparing the Effectiveness of Amruthadi Kashaya and Haridrakhanda in Treating Sheetapitta ( urticaria)
Scientific Title of Study
A RANDOMIZED OPEN-LABEL CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF AMRUTHADI KASHAYA IN THE MANAGEMENT OF SHEETAPITTA WITH SPECIAL REFERENCE TO URTICARIA AND COMPARE WITH THE EFFICACY OF HARIDRAKHANDA
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 GAYATHRI KRISHNAKUMAR
Designation
PG SCHOLAR
Affiliation
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL
Address
ROOM NO 5 DEPARTMENT OF KAYACHIKITSA SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL
KANAKAPURA ROAD UDAYAPURA BENGALURU KARNATAKA 560082
Bangalore KARNATAKA 560082 India
Phone
8281979807
Fax
Email
drgayathrikrishnakumar20@gmail.com
Details of Contact Person Scientific Query
Name
DR GOPALAKRISHNA G
Designation
PROFESSOR AND HEAD OF DEPARTMENT
Affiliation
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL
Address
ROOM NO 5 DEPARTMENT OF KAYACHIKITSA SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL
KANAKAPURA ROAD UDAYAPURA BENGALURU KARNATAKA 560082
Bangalore KARNATAKA 560082 India
Phone
9448173128
Fax
Email
lakshmimp1981@gmail.com
Details of Contact Person Public Query
Name
DR GOPALAKRISHNA G
Designation
PROFESSOR AND HEAD OF DEPARTMENT
Affiliation
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL
Address
ROOM NO 5 DEPARTMENT OF KAYACHIKITSA SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL
KANAKAPURA ROAD UDAYAPURA BENGALURU KARNATAKA 560082
Bangalore KARNATAKA 560082 India
Phone
9448173128
Fax
Email
lakshmimp1981@gmail.com
Source of Monetary or Material Support
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL
KANAKAPURA ROAD UDAYAPURA BENGALURU KARNATAKA 560082 INDIA
Primary Sponsor
Name
DR GAYATHRI KRISHNAKUMAR
Address
ROOM NO 5 DEPARTMENT OF KAYACHIKITSA SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL
KANAKAPURA ROAD UDAYAPURA BENGALURU KARNATAKA 560082
Type of Sponsor
Other [SELF]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
DR GAYATHRI KRISHNAKUMAR
Sri Sri College of Ayurvedic Science and Research hospital
ROOM NO 5 KAYACHIKITSA OPD SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL
21st KM KANAKAPURA ROAD UDAYAPURA BENGALURU KARNATAKA 560082 Bangalore KARNATAKA
1 Patients presenting with classical signs and symptoms of sheetapitta such as varatee dashta
samsthana shotha,kandu and toda
2 Patients exhibits symptoms falling within mild to moderate range on the UAS urticaria scale.
3 Subjects willing to participate with written informed consent, which is conveyed in the
language, which the subject can understand.
ExclusionCriteria
Details
1.Pregnant or lactating women.
2. Presence of uncontrolled systemic disorders such as diabetic mellitus,
hypertention, IHD that may interfere course of disease or treatment response.
3. Known hypersensitivity or allergy to ingredients of the intervention
drug or formulation
4. Use of systemic antihistamines, corticosteroids, immunomodulators.
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
Alternation
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To clinically evaluate the efficacy of Amruthadi kashaya in the management of Sheetapitta with special reference to Urticaria based on subjective and objective parameters in the Institutional clinical setup
0th day -pre-test assessment with subjective and UAS scale
31st day – post-test assessment with subjective and UAS scale
46th day – as drug free follow-up assessment with subjective and UAS scale
Secondary Outcome
Outcome
TimePoints
1. To assess the quality of life of patients through General Health Questionnaire Scale.
2.To undertake the detailed literary review of Sheetapitta ,Amruthadi Kashaya
,Haridrakhanda for study of sheetapitta with special reference to Urticaria
3.To record and report adverse effect (if any ) during the study period
0th day -pre-test assessment with subjective and UAS scale
31st day – post-test assessment with subjective and UAS scale
46th day – as drug free follow-up assessment with subjective and UAS scale
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
Date of First Enrollment (India)
10/03/2026
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="1" Months="6" 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 skin condition marked by temporary dermal swelling and itching caused by increased capillary permeability. Globally affecting over 65 million people, it significantly reduces quality of life. While modern treatments rely on antihistamines, steroids, and biologics, these often carry risks of sedation, weight gain, or high costs.
In Ayurveda, this condition is identified as Sheetapitta, a Vata-dominant disorder affecting the Rasa and Rakta tissues. It manifests as painful, red, wasp-sting-like wheals, often triggered by cold exposure or improper diet. While not detailed as a primary disease in the major ancient texts like the Brihatrayee, it is extensively covered in later works like Madhava Nidana.
This study evaluates the efficacy of Amruthadi Kashaya, a decoction sourced from the Yogaratnakara, in relieving Sheetapitta symptoms. It uses Haridrakhanda from the Bhaishajya Ratnavali as a proven control drug to establish a comparative clinical baseline.