| CTRI Number |
CTRI/2022/12/047941 [Registered on: 07/12/2022] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Zasdamrut tablets in the patients with Acute Upper Respiratory Tract Infections (URTI) |
|
Scientific Title of Study
|
An open label randomized comparative clinical study to evaluate the efficacy of Zasdamrut in Acute Upper Respiratory Tract Infections |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anbuselvam A |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD No 116
Department of Kayachikitsa
Parul Ayurved Hospital
Parul University
PO Limda Tal Waghodia
Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8921748070 |
| Fax |
|
| Email |
kalpanaanbu123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu R |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD No 116
Department of Kayachikitsa
Parul Ayurved Hospital
Parul University
PO Limda Tal Waghodia
Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9481328930 |
| Fax |
|
| Email |
dr.manurajgopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anbuselvam A |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD No 116
Department of Kayachikitsa
Parul Ayurved Hospital
Parul University
PO Limda Tal Waghodia
Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8921748070 |
| Fax |
|
| Email |
kalpanaanbu123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved, Parul University |
|
|
Primary Sponsor
|
| Name |
Dean and Principal Faculty of Parul Institute of Ayurved |
| Address |
Parul institute of Ayurved
Parul University
Limda
Gujarat |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Solumiks herbaceuticals ltd |
135, Nanubhai Desai Road, Khetwadi, Mumbai-400004, Maharashtra, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anbuselvam A |
Parul Ayurved Hospital |
OPD 116 Department of Kayachikitsa Parul Ayurved Hospital
Parul University
Limda Gujarat
Vadodara
GUJARAT |
8921748070
kalpanaanbu123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee of Parul institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Zasdamrut, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 600(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Sukhoshna jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tribhuvankeerti Rasa, Reference: Yogaratnakara Jwara Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of either gender between 18 and 60 years (Both years inclusive)
2 Patients with symptoms on the basis of Jackson Downing URTI scale
3 Those who gives consent and assent as per requirement |
|
| ExclusionCriteria |
| Details |
1 Patients with Chronic bronchial asthma
2 Patients with tuberculosis
3 Patients with severe lower RTI (pneumonia, emphysema, bronchiectasis) or associated with other systemic illness
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment on the basis of Jackson Downing URTI scale |
Assessment will be done on day 0, day 3rd or 4th, day 7th and day 14th (without medicine) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment on the basis of CBC, CRP, AEC, MP (Malarial Parasite), Dengue NS-1 |
Assessment will be done on baseline (day 0) and day 7th |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
09/12/2022 |
| Date of Study Completion (India) |
25/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/10/2023 |
|
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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Upper respiratory Tract infection (URTIs) is one of the most common diseases among
adults, who generally experience infections for two to five times a year. Upper respiratory
tract infections such as laryngitis, pharyngitis, nasopharyngitis, and rhinitis, are among the
most common diseases in primary medical care. The majority of URTI’s are of viral origin, due to rhinovirus, parainfluenza virus, corona
virus, adenovirus, coxsackie virus, and influenza virus. Only 10% of URTI has been
attributed to bacterial etiology. The management of URTI of viral origin involves
symptomatic treatment like antihistamines, antipyretics or anti-inflammatory agents, cough
suppressants, expectorants and decongestants. Antibiotic treatment is beneficial only if symptoms persist for 10-14 days without
improvement. Hence it poses a challenge to the clinicians to differentiate between viral and
bacterial origin of URTI. In India, several studies have reported that 45% to 86% of URTI cases
are treated with antibiotics. This is despite large amounts of evidence on the self-limiting nature
of acute URTI. Problems associated with the overuse of antibiotics include development of
bacterial resistance, increasing the burden of chronic disease, raising the cost of health services
and the development of side effects. Hence there is need of better alternative treatment for the management of URTI. In this study, Zasdamrut tablet will be given to the patients with URTI for 7 days, and assessment will be done on the basis of Jackson Downing scale and on different blood parameters. |