CTRI Number |
CTRI/2022/09/045654 [Registered on: 19/09/2022] Trial Registered Prospectively |
Last Modified On: |
05/02/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
Ayurvedic Management in Urticaria |
Scientific Title of Study
|
A Clinical studty to evaluate the Role of Virechanottara Udwartana in Sheetapitta with special reference to Chronic Urticaria |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Uma Mantha |
Designation |
PG Scholar |
Affiliation |
Dr. BRKR Govt Ayurvedic Medical College |
Address |
Dr. BRKR Govt Ayurvedic Medical College , S.R.Nagar Hyderabad
500038 Dr. BRKR Govt Ayurvedic Medical College , S.R.Nagar Hyderabad
500038 Hyderabad TELANGANA 500038 India |
Phone |
9491854040 |
Fax |
|
Email |
dr.umabutta71@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr M Praveen Kumar |
Designation |
Associate Professor |
Affiliation |
Dr. BRKR govt Ayurvedic Medical College |
Address |
Room No 5, Panchakarma O.P.
Dr. BRKR Govt Ayurvedic Medical College, S.R. Nagar, Hyderabad
Room No 5, Panchakarma O.P.
Dr. BRKR Govt Ayurvedic Medical College, S.R. Nagar, Hyderabad
Hyderabad TELANGANA 500038 India |
Phone |
9849271601 |
Fax |
|
Email |
pkmadikonda@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Uma Mantha |
Designation |
PG Scholar |
Affiliation |
Dr. BRKR Govt Ayurvedic Medical College |
Address |
Room No. 5, Dr. BRKR Govt Ayurvedic Medical College , S.R.Nagar Hyderabad
500038 Dr. BRKR Govt Ayurvedic Medical College , S.R.Nagar Hyderabad
500038 Hyderabad TELANGANA 500038 India |
Phone |
9491854040 |
Fax |
|
Email |
dr.umabutta71@gmail.com |
|
Source of Monetary or Material Support
|
Dr.BRKR Govt Ayurvedic Medical College Hyderabad. |
|
Primary Sponsor
|
Name |
Dr BRKR Govt Ayurvedic medical college |
Address |
Dr. BRKR Govt Ayurvedic Medical College S.R.Nagar Hyderabad Telangana 500038 |
Type of Sponsor |
Government 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 M Uma |
Govt Ayurvedic Hospital |
Room no 5,Department of Panchakarma, Govt Ayurvedic Hospital, S.R. Nagar, Hyderabad. Hyderabad TELANGANA |
9491854040
dr.umabutta71@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:L50||Urticaria. Ayurveda Condition: SITAPITTAM, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | AByantarasnehaH , आà¤à¥à¤¯à¤¨à¥à¤¤à¤°Â सà¥à¤¨à¥‡à¤¹à¤ƒ | (Procedure Reference: Baishajya Ratnavali, Procedure details: Mahatiktaka gritha
) (1) Medicine Name: Triphaladi Yoga, Reference: Baishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Duration: 1 Days | 2 | Intervention Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: Baishajya Ratnavali, Procedure details: Sarshapa Taila) (1) Medicine Name: Sarshapa taila, Reference: Baishajya Ratnavali, Route: Otic, Dosage Form: Taila, Dose: 150(ml), Frequency: od, Duration: 3 Days | 3 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Baishajya Ratnavali, Procedure details: Triphaladi yoga with Eranda taila) (1) Medicine Name: Triphaladi Yoga, Reference: Baishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Duration: 1 Days | 4 | Intervention Arm | Procedure | - | udvartanam, उदà¥à¤µà¤°à¥à¤¤à¤¨à¤®à¥ | (Procedure Reference: Baishajya Ratnavali, Procedure details: Siddarthakadi Yoga) (1) Medicine Name: Siddarthakadi Yoga, Reference: Baishajya Ratnavali, Route: Topical, Dosage Form: Churna/ Powder, Dose: 150(g), Frequency: sos, Duration: 14 Days |
|
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1 Urticaria more than 6 weeks.
2 Patients fit for Purgation therapy vis a vis Virechana karma. |
|
ExclusionCriteria |
Details |
1 Urticaria less than 6 weeks duration
2 Patients suffering with other skin diseases such as Eczema, Psoriasis
3 Patient unfit for Purgation therapy vis a vis Virechana karma
4 Tuberculosis, HIV, HbsAg
5 Major systemic disorders, un controlled Diabetes
6 Patients suffering with Severe form of Angioedema
7 Drug induced Urticaria |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Average change from baseline in following parameters: 1. Severity of pruritus over last 24 hours. 2. Rating of number of wheals. |
Assessment done on base line visit (day 0), and after 4 weeks of treatment
|
|
Secondary Outcome
|
Outcome |
TimePoints |
To Improve the quality of life |
Assessment done on base line and after8 weeks of treatment
|
|
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 1 |
Date of First Enrollment (India)
|
19/09/2022 |
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)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Chronic Urticaria (CU) is a common dermatological condition affecting an estimated 15-20% of the general population at least once during the life time. Urticaria causes inconvenience in family structures, compromising performance at work, school, and negatively impacting on leisure activities. Urticaria is a mast-cell-driven disease. Histamine and other mediators, such as platelet-activating factor (PAF) and cytokines released from activated mast cells, result in sensory nerve activation, vasodilatation, and plasma extravasations as well as cell recruitment urticarial lesions. Contemporary modern medicine does not have complete cure for Urticaria. Modern second-generation antihistamines are considered as the first-line symptomatic treatment for urticaria and these medicines have undesirable side effects such as drowsiness, dry mouth, weight gain and increased resistance to infections. The symptoms of urticaria is comparable to sheetapitta. The main focus of the present therapies aimed at symptomatic relief. Panchakarma therapies helps in cleansing the body and also helps in detoxification. The hyper immune response is seen in urticaria is countered effectively with panchakarma therapies. Virechana karma is one among the panchakarma therapy. Virechana Karma is a simple method of shodhana therapy which acts on sleshmasamsrusta pittaja vyadhi. After samshodhana, udwarthana can be used to ensure better results in sheethapitta vis-a vis Urticaria. This study is designed as single arm study in patients with Virechanottara Udwarthana. After screening, patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on baseline, 10th and 50th day of treatment. This includes subjective assessment of general wellbeing, weekly UAS7 scores and physical examination. The total duration of treatment will be 50 days. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy. |