| CTRI Number |
CTRI/2024/12/078684 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Trial of Amrutadi Syrup in Urticaria |
|
Scientific Title of Study
|
An Open Labelled Randomized Controlled trial to evaluate the efficacy of ‘Amrutadi Kashaya’ in the
management of Sheetpitta with special reference to 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 |
Yogesh Tukaram Kotangale |
| Designation |
Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College Hadapsar Pune |
| Address |
OPD NO. 2
First Floor
Kayachikitsa Department
Malwadi Hadapsar Pune
First Floor
Pune
MAHARASHTRA
411028
India |
| Phone |
09423218193 |
| Fax |
|
| Email |
drytk@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krutika Ramesh Jangale |
| Designation |
P.G. student |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College Hadapsar Pune |
| Address |
OPD NO. 2
First Floor
Kayachikitsa Department
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
09168722181 |
| Fax |
|
| Email |
krutikajangalekruz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krutika Ramesh Jangale |
| Designation |
P.G. student |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College Hadapsar Pune |
| Address |
OPD NO. 2
First Floor
Kayachikitsa Department
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
09168722181 |
| Fax |
|
| Email |
krutikajangalekruz@gmail.com |
|
|
Source of Monetary or Material Support
|
| SANEGURUJIN AROGYA KENDRA |
|
|
Primary Sponsor
|
| Name |
Dr Krutika Ramesh Jangale |
| Address |
OPD NO. 2
First Floor
Kayachikitsa Department
MALWADI HADAPSAR PUNE |
| Type of Sponsor |
Private medical college |
|
|
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 Krutika Ramesh Jangale |
Saneguruji Arogya Kendra |
OPD NO. 2
First Floor
Kayachikitsa Department
MALWADI HADAPSAR PUNE
Pune
MAHARASHTRA |
09168722181
krutikajangalekruz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra |
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 | Comparator Arm (Non Ayurveda) | | - | HYDROXYZINE HYDROCHLORIDE | 10 mg once a day at night with normal water | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: AMRUTADI KASHAYA, Reference: BHAISHAJY RATNAWALI, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: KOSHNA JALA), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 The age limit is from 18 to 70 years.13
2 Patient suffering from Cardinals signs Mandalotpatti,Kandu and Associated symptoms
of Sheetpitta (Urticaria) Daha,Toda,Jwar,Chhardi.
3 Patients with reocurrence within 6 months will be included.
4 Patients will be selected irrespective of Sex & Socioeconomic status. |
|
| ExclusionCriteria |
| Details |
1 Pregnant and lactating women.
2 Patients with severe vomiting, diarrhoea and those who cannot take medicine orally.
3 Sheetpitta along with other chronic diseases and their associated complications.
4 Patient having major medical or surgical Illness.
5 Patients with a history of systemic illness like Diabetes mellitus, Hypertension,
Endocrine disorder, Cardiac pathology, and Immunodeficiency disorders like AIDS.
6 Patient with drug-induced Sheetpitta (Urticaria). |
|
|
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 evaluate the efficacy of Amrutadi Kashaya in the management of Sheetpitta |
15 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
01/01/2025 |
| 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 Applicable |
| 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
|
Sheetpitta (Urticaria) is one of the most common dermatoses found as compared to other skin-related diseases. Although Sheetpitta is not a life-threatening disease, it makes patients worried due to its appearance and intense itching which disturbs their regular routine. It is estimated that about 1 in 5 (20%) people will have urticaria once in their lifetime and this seems to be the case across all age groups.6 In Sheetpitta, reoccurrence is a common event. In modern science, it has only symptomatic treatment (with antihistamines and steroids) and does not constitute a complete cure. Prolonged administration is often required, this places the patient at risk of adverse effects. Sheetpitta is a Tridoshaj Vyadhi. Treatment for Sheetpitta according to Ayurveda includes both Shodhan and Shaman chikitsa. Various Aushadhi Yoga is mentioned for Udarda and Kotha which can also be used for Sheetpitta. The main advantage of ayurvedic treatment is that it helps to control the recurrence and severity of Sheetpitta with the correct use of Shodhan and Shaman chikitsa and Pathya-Apathya Palana. |