CTRI Number |
CTRI/2023/05/052556 [Registered on: 12/05/2023] Trial Registered Prospectively |
Last Modified On: |
11/05/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
A study on kotha w.s.r. urticaria and its management with dushivishari agada and saindhavadi yoga |
Scientific Title of Study
|
A study on kotha with special reference to urticaria and its management with dushivishari agada and saindhavadi yoga |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR RAHUL SADIWAL |
Designation |
PG SCHOLAR AGAD TANTRA EVUM VIDHI VAIDYAKA |
Affiliation |
Pt. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL |
Address |
Science hills behind manit kolar nehru nagar
Bypass road bhopal bhopal madhya pradesh 462003
India
Bhopal
Madhya pradesh
462003
India
Department of agad tantra evum vidhi vaidyaka
room no-228 Bhopal MADHYA PRADESH 462001 India |
Phone |
7898452041 |
Fax |
|
Email |
rsadiwal60@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR URMILA SHUKLA |
Designation |
PROFESSOR AND HOD OF DEPT OF AGAD TANTRA EVUM VIDHI VAIDYAKA |
Affiliation |
Pt. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL |
Address |
Room no 229 science hills behind manit kolar nehru nagar
Bypass road bhopal bhopal madhya pradesh 462003
India
Bhopal
MADHYA PRADESH
462003
India
Bhopal MADHYA PRADESH 462003 India |
Phone |
9425672655 |
Fax |
|
Email |
drurmilashukla5@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR RAHUL SADIWAL |
Designation |
MD SCHOLAR AGAD TANTRA EVUM VIDHI VAIDHYAKA |
Affiliation |
Pt. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL |
Address |
SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR
BYPASS ROAD BHOPAL BHOPAL MADHYA PRADESH 462003
INDIA
Bhopal
MADHYA PRADESH
462003
India department of agad tantra evum vidhi vaidyaka room no 228 Bhopal MADHYA PRADESH 462001 India |
Phone |
7898452041 |
Fax |
|
Email |
RSADIWAL60@GMAIL.COM |
|
Source of Monetary or Material Support
|
Pt. KHUSHILAL SHARMA GOVT.(AUTO.) AYURVEDA COLLEGE AND INSTITUTE, BHOPAL,
MP |
|
Primary Sponsor
|
Name |
Pt KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
Address |
SCIENCE HILLS BEHIND MANIT, KOLAR NEHRU NAGAR
BYPASS ROAD,BHOPAL BHOPAL MADHYA PRADESH 462003
INDIA |
Type of Sponsor |
Research institution and hospital |
|
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 rahul sadiwal |
Pt khushilal sharma govt auto ayurveda college and institute bhopal |
Department of agad tantra evum vidhi vaidyaka science hills
Behind manit,
Kolar nehru
Nagar bypass
Road,bhopal
Bhopal madhya
Pradesh 462003
India
Bhopal
Madhya pradesh
Bhopal MADHYA PRADESH |
7898452041
rsadiwal60@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:L509||Urticaria, unspecified. Ayurveda Condition: KOTHAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dooshivishari gutika, Reference: sushruta kalp2/30, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: medicine will be prepared in the form of gutika and prescribed to pt in bid dose(2) Medicine Name: saindhavadi yoga`, Reference: yogratnakar sheetpittodard chapter shlok no 12, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: one medicine dooshivishari gutika will be given internally and second medicine saindhavadi yoga will be given for local application as external medicine(saindhavadi yoga will be given as required | 2 | Comparator Arm (Non Ayurveda) | | - | placibo | 250mg capsule filled with roasted suji bid for 30 days |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients having cardinal sign and symptoms of Kotha (Urticaria), as in Ayurvedic classics and contemporary medicine.
AEC (absolute eosinophil count value is > 500 cells/cmL
Diagnosed mild and moderate cases of Urticaria.
|
|
ExclusionCriteria |
Details |
1.Patient having disease like urticaria with angioedema, diabetes mellitus, tuberculosis, severe cardiac disease,
2.Patients having major systemic illness.
3.Pregnant and lactating mothers will be excluded.
4.Patient without written consent form.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
after completion the study,we will be able to demonstrate that Dushivishari Agada and Saindhavadi yoga is effective in management of Kotha (Urticaria) |
30 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
after completion of study i would be able to explain that Dushivishari Agada and Saindhavadi yoga are not effective in the management of Kotha (Urticaria) |
30 days |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
20/05/2023 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Urticaria is allergic reaction marked by
multiple discrete swelling on the skin that are intensely itchy and last up to 24 hrs. it is caused by hyper sensitivity of the immune system. In present scenario people are using many types of products and food items, containing many
hazardous chemicals. Use of beverages, food adulteration, preservatives, additives, fruit
ripping agents, different chemicals, pesticides are the form of artificial poison. These chemicals
get deposited in the system and remain in the form of latent poison(dooshivisha acc to ayurveda).These poisons trigger the
immunity of the person, which ultimately results in hyper sensitivity of the immune system. the Urticaria or
hives is a common skin condition that affects population with a lifetime prevalence of up to
22% and point prevalence of 1%. Approximately 4–33% of cases are reported to be physical
urticaria and 1–7% of cases are cholinergic urticaria. It is expected that at the end of study we would be able to demonstrate the efficacy of Dushivishari Agada and Saindhavadi Yoga in the management of kotha w.s.r. Urticaria. |