| CTRI Number |
CTRI/2022/05/042427 [Registered on: 10/05/2022] Trial Registered Prospectively |
| Last Modified On: |
18/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Assess causative Factors of Sheetapitta (Urticaria) and relieving effect of Amrutadi Ghana Vati along with Ksharsindutha Tail (Oleation therapy) |
|
Scientific Title of Study
|
To Assess Etiological Factors of Sheetapitta (Urticaria) and Upshayatmaka effect of Amrutadi Ghana Vati along with Ksharsindutha Tail (Abhyangartha) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anand More |
| Designation |
Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Roga Nidan Evum Vikriti Vigyan 3rd floor C Block
All India Institute of Ayurveda
Gautam Puri
New Delhi 110076
All India Institute of Ayurveda
Gautam Puri
New Delhi 110076
South
DELHI
110076
India |
| Phone |
9422025732 |
| Fax |
|
| Email |
drmoreanand@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand More |
| Designation |
Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Roga Nidan Evum Vikriti Vigyan 3rd Floor C Block
All India Institute of Ayurveda
Gautampuri
New Delhi 110076
All India Institute of Ayurveda
Gautampuri
New Delhi 110076
South
DELHI
110076
India |
| Phone |
9422025732 |
| Fax |
|
| Email |
drmoreanand@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand More |
| Designation |
Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Roga Nidan Evum Vikriti Vigyan 3rd Floor C Block
All India Institute of Ayurveda
Gautampuri
New Delhi 110076
All India Institute of Ayurveda
Gautampuri
New Delhi 110076
South
DELHI
110076
India |
| Phone |
9422025732 |
| Fax |
|
| Email |
drmoreanand@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india Institute of Ayruveda |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda
Gautampuri
New Delhi 110076 |
| 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 Md Amir Maqsood |
All india institute of Ayurveda |
OPD NO.1 HOSPITAL BLOCK, ALL INDIA INSTITUTE OF AYURVEDA GAUTAM PURI NEW DELHI 110076
South
DELHI |
9718206816
aamirmaqsood95@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:L500||Allergic urticaria. Ayurveda Condition: SITAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: AMRUTADI GHAN VATI, Reference: YOG RATNAKAR, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -(2) Medicine Name: ksharsindutta, Reference: Chakradutta, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -tail will be used for abhyang on affected areas. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients showing clinical features of sheetapitta.
2.Willing to participate in study with age gruop of
18-60 years, irrespective of their gender,religion, economic
.status.
3.Chornicity more than 6 weeks and had experienced
of minimum 3 attacks.
4.Gender- both |
|
| ExclusionCriteria |
| Details |
1.With severe systemic disorders like-DM,CKD etc.
2.Pregnant women and Lactating mother.
3.Other skin disease e.g.Psoriasis.
4.Acute whole body urticaria. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relieve in symptoms of Sheetapitta(urticaria) i.e varati danshtravat shotha (wheals), kandu. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="41" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2022 |
| Date of Study Completion (India) |
02/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Research Question- Whether Nidana described in Ayurveda Classics determine Etiological factors of sheetapitta (Urticaria) in current era and if Amrutadi ghana vati along with Ksharsindutha tail (abhyangartha) has any Upshayatmaka effect in the same ?
Hypothesis - Nidana mentioned in Ayurveda do have significant role in etiopathogenesis of Sheetapitta (Urticaria) in current era and Amrutadi ghana vati along with Ksharsindutha tail (abhyangartha) has Upshayatmaka effecti in it.
Null Hypotheis - Nidana as mentioned in Ayurveda may not have significant role in the etiopathogenesis of sheetapitta (Urticaria) in current era and Amrutadi ghana vati along with Ksharsindutha tail (abhyangartha) has no Upshayatmaka effect in it.
Intervention Drugs 1. Amrutadi ghana vati 250mg BD with Leukwarm water for 30 days 2. Ksharsindutha tail for abhyanga according to affected area before bath 30 days.
|