| CTRI Number |
CTRI/2023/09/057896 [Registered on: 20/09/2023] Trial Registered Prospectively |
| Last Modified On: |
29/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Ayurvedic Formulation Patanjali Typhogrit in subjects with Typhoid Fever. |
|
Scientific Title of Study
|
Evaluate the efficacy of Indian Ayurvedic Formulation Typhogrit in subjects with Typhoid Fever: A Single-Arm, Open-Label, Prospective Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devasena K M |
| Designation |
Medical Research Associate |
| Affiliation |
Patanjali Research Foundation |
| Address |
Patanjali Research Foundation, Near Patanjali Yogpeeth-1, NH-58 Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
249405
India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7012421624 |
| Fax |
|
| Email |
drdevasenabamsmd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devasena K M |
| Designation |
Medical Research Associate |
| Affiliation |
Patanjali Research Foundation |
| Address |
Patanjali Research Foundation, Near Patanjali Yogpeeth-1, NH-58 Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
249405
India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7012421624 |
| Fax |
|
| Email |
drdevasenabamsmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Singh Tyagi |
| Designation |
Clinical Research Associate |
| Affiliation |
Patanjali Research Foundation |
| Address |
Patanjali Research Foundation, Near Patanjali Yogpeeth-1, NH-58 Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
249405
India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7351925692 |
| Fax |
|
| Email |
shubham.tyagi@patanjali.res.in |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation governed by Patanjali Research Foundation Trust |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation governed by Patanjali Research Foundation Trust |
| Address |
Patanjali Research Foundation, Opp. Patanjali Yogpeeth-1, Maharishi Dayanand Gram, Delhi-Haridwar National Highway, Near Bahadrabad, Haridwar, Uttarakhand, India-249405 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devasena K M |
Patanjali Wellness Center |
Room No.69, PATANJALI WELLNESS LIMITED, CIN No.-U74120 UR2009 PTCO32907
Hardwar
UTTARANCHAL |
7012421624
drdevasenabamsmd@gmail.com |
| Dr Devasena K M |
Patanjali Yoggram |
Room No-10, Yog Naturopathy Panchkarma Treatment & Research Centre (Yoggram) Subsidiary unit of Patanjali Yogpeeth., Near Sidcul, Aurangabad, Haridwar (Uttarakhand), PIN Code: 249402.
Hardwar
UTTARANCHAL |
07012421624
drdevasenabamsmd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Approved |
| Institutional Ethics Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B998||Other infectious disease. Ayurveda Condition: VISHAJAJVARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Typhogrit, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed with Typhoid fever (Qualitative result as positive on Rapid Typhoid Dot Test Report) - The subjects who will be diagnosed by physician in clinic or having the history of diagnosed Typhoid fever.
2. Subjects with temperature more than 1000 F
3. Males or Females of age limit 18 years to 75 years.
4. Subjects willing to participate and give consent for the study.
5. Capability for complete compliance and completion of follow-up.
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy or lactation, intent to become pregnant.
2. Diagnosis of other bacterial and viral fever than Typhoid fever.
3. Subjects not willing to participate and give consent for the study.
4. The subject with a known history of any malignancy, uncontrolled diabetes mellitus, psychiatric disorders, or with complications of Cardiovascular diseases, liver diseases or kidney disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in subject’s condition including general health and fever. |
Baseline, Day 15, Day 30, Day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •To assess the changes in the values of Multidimensional Fatigue Inventory (MFI), Visual Analog Scale (VAS) & Patient’s Global Impression of Change (PGIC) |
Baseline, Day 15, Day 30, Day 45 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
28/09/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a single-arm, open-label, prospective, interventional study. In this study, 50 participants will be enrolled aged 18-75 years. Participants will receive intervention with medication for 45 days. The primary outcome records the changes in the participant’s condition after 45 days of treatment and the secondary outcome involves changes in the values of the Multidimensional Fatigue Inventory (MFI), Visual Analog Scale (VAS)& Patient’s Global Impression of Change (PGIC). |