| CTRI Number |
CTRI/2023/06/053565 [Registered on: 05/06/2023] Trial Registered Prospectively |
| Last Modified On: |
29/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Parnayavani swarasa as an adjuvant in the management of Sheetapitta w.s.r to Urticaria |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of Parnayavani swarasa as an adjuvant in the management of Sheetapitta w.s.r to Urticaria |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushmitha Bharadwaj H G |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri college of Ayurvedic science and research |
| Address |
Department of PG studies in Swasthavritta. Sri Sri college of Ayurvedic science and research,21st KM Kanakapura road, Udhayapura post, Bengaluru 560082. Karnataka
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9481765870 |
| Fax |
|
| Email |
sushmitabharadwaj04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sajitha k |
| Designation |
Head of the department, Professor |
| Affiliation |
Sri Sri college of Ayurvedic science and research |
| Address |
Department of PG studies in Swasthavritta. Sri Sri college of Ayurvedic science and research,21st KM Kanakapura road, Udhayapura post, Bengaluru 560082. Karnataka
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9448415810 |
| Fax |
|
| Email |
sajithak96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajitha k |
| Designation |
Head of the department, Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of PG studies in Swasthavritta. Sri Sri college of Ayurvedic science and research,21st KM Kanakapura road, Udhayapura post, Bengaluru 560082. Karnataka
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9448415810 |
| Fax |
|
| Email |
sajithak96@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
|
|
Primary Sponsor
|
| Name |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH,21st KM Kanakapura road, Udhayapura post, , bengaluru 560082. Karnataka |
| 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 Sushmitha Bharadwaj H G |
Sri Sri Ayurveda Hospital |
Department of Swasthavritta, OPD number 07, O.B. Chordahalli, Udhayapura post, Bengaluru 560082. Karnataka
Bangalore Rural
KARNATAKA |
9481765870
sushmitabharadwaj04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L509||Urticaria, unspecified. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Parnayavani, Reference: Priya Nighantuh, Shatapushpadi varga, 11/17-18, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -to take as adjuvant with 3g Haridra khanda | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridra kanda, Reference: Bhaisajya ratnavali of Shastri RD, 55th chapter, Sloka no. 13-17, Route: Oral, Dosage Form: Khanda /Granules, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients showing minimum of 3 classical clinical feature of Sheetapitta.
2. Patients of age group between 21 to 60 years will be included irrespective of their gender, religion, marital status and socioeconomical status.
3. Subjects who are willing to participate in the study by giving the written consent
|
|
| ExclusionCriteria |
| Details |
1.Patients having associative symptoms like vomiting, fever and suffering from any other infections or systemic disorders.
2.History of angioedema and other skin disease like psoriasis, eczema.
3.History of anaphylaxis to medicine.
4.Subjects who are pregnant and lactating.
5.Subjects who are not willing to participate in the study.
|
|
|
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreased symptoms of Urticarial rashes |
0th, 14th, 20th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in AEC count |
0th, 14th, 20th day |
|
|
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)
|
20/06/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study type - Randomized Active controlled clinical study, Pre and post test study, Timing - Prospective, Masking - Open label, Grouping - Double arm, Randomization - Lottery method, Group intervention method - Parallel| FEATURES | GROUP A - TRIAL GROUP | GROUP B - CONTROL GROUP | | SAMPLE SIZE | 15 | 15 | | INTERVENTION | 3grams of Haridrakhanda
and 12ml of Parnayavani
Swarasa,BD | 3grams
of Haridrakhanda, BD | | ROUTE | Oral | Oral | | TIME OF ADMINISTRATION | After food twice daily
| After food twice daily
| | TRIAL PERIOD | 14 days | 14 days | | FOLLOW UP PERIOD | 14th
day and 20th day | 14th
day and 20th day | | STUDY PERIOD | 20 days | 20 days |
|