| CTRI Number |
CTRI/2022/07/044249 [Registered on: 22/07/2022] Trial Registered Prospectively |
| Last Modified On: |
20/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Anu Taila nasya(nasal drop) and Shatyadi Vati(tablet)in Vataja Pratishyaya(Allergic Rhinitis) |
|
Scientific Title of Study
|
"Evalution of Anu-Taila Nasya and Shatyadi Vati in Vataja Pratishyaya"(Allergic Rhinitis)" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arun kumar |
| Designation |
Assistant professor |
| Affiliation |
Rishikul Campus Haridwar UAU Harrawala Dehradoon |
| Address |
OPD no 5 PG Department of Shalakya Tantra Department Sushuruta Bhawan Rishikul Campus Haridwar
Hardwar
UTTARANCHAL
249401
India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9634918909 |
| Fax |
|
| Email |
drarun2004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun kumar |
| Designation |
Assistant professor |
| Affiliation |
Rishikul Campus Haridwar UAU Harrawala Dehradoon |
| Address |
OPD no 5 PG Department of Shalakya Tantra Department Sushuruta Bhawan Rishikul Campus Haridwar
Hardwar
UTTARANCHAL
249401
India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9634918909 |
| Fax |
|
| Email |
drarun2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arti Panwar |
| Designation |
PG Scholar |
| Affiliation |
Rishikul Campus Haridwar UAU Harrawala Dehradoon |
| Address |
OPD no 5 PG Department of Shalakya Tantra Department Sushuruta Bhawan Rishikul Campus Haridwar
Hardwar
UTTARANCHAL
249401
India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9758274121 |
| Fax |
|
| Email |
artipanwarsep07@gmail.Com |
|
|
Source of Monetary or Material Support
|
| Rishikul campus uttarakhand ayurveda university harrawala Dehradoon |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurveda University |
| Address |
Uttarakhand Ayurveda University Harrawala Dehradun |
| 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 Arti Panwar |
Rishikul campus Uttarakhand Ayurveda University haridwar |
OPD No-5 Department of Shalakya Tantra Rishikul Campus Uttakhand Ayurveda University Harrawala Dehradun
Hardwar
UTTARANCHAL |
9758274121
artipanwarsep07@gmail.Com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Uttarakhand Ayurveda University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00||Acute nasopharyngitis [common cold]. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: charak chikitsa 26/139-40, Procedure details: 3 sitting Marsha nasya- 8 drops in each nostril(once in a day )for 7 days
2 sitting Pratimarsha nasya -2 drops in each nostril (once in a day) for 7 days )
(1) Medicine Name: Shatyadi vati , Reference: yog ratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 35 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient Suffering From Vataja Pratisyaya(Allergic Rhinitis).
2)Age between 16-60 years irrespective of sex.
3)Chronicity Up to 2 Years |
|
| ExclusionCriteria |
| Details |
1)Any individual above 60 years and below 16 years of age either of any sex.
2) Suffering from Rhinitis other than Allergic Rhinitis.acute/chronic sinusitis,other pathology like-DNS,polyp,Trauma to nose
3)Known case of chronic systemic disease like-DM,HTN,Tuberculosis,Lower Respiratory Tract Diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of Vataja Pratishayaya like sneezing,rhinorrhea,headache etc |
1st,15th,35th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in sneezing,running nose and nasal obstruction |
1st,15th,35th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2022 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Method Of Treatment Selected Drugs :Anu Taila ,Shatyadi VatiForm of Medicine :Anu Taila -Oil Shatyadi Churna- Vati (Tablets) Composition Of Medicine: Anu Taila -Dashmoola,Mulethi,Rashna,Saindhava,Tila Seeds(black),Ajadugdha Shatyadi Vati- Shathi,Bhoomiamalki,Trikatu.
Dose of Medicine- Anu Taila -Marsha Nasya-8 Drops in Each nostril (Once in a day) Pratimarsha Nashya- 2 Drops in Each Nostril (Once in a day) Shatyadi Vati -1 tab 500mg BD Orally
|