| CTRI Number |
CTRI/2022/09/045277 [Registered on: 07/09/2022] Trial Registered Prospectively |
| Last Modified On: |
09/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Yashada bhasma in healthy human volunteers |
|
Scientific Title of Study
|
Pharmaceutical-Analytical study of Yashada bhasma and its estimation in serum of healthy human volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Veda SM |
| Designation |
PG scholar |
| Affiliation |
Government Ayurvedic Medical College, Bangalore |
| Address |
Dept of RSBK,
GAMC,Bangalore
Bangalore
KARNATAKA
560009
India |
| Phone |
8762532179 |
| Fax |
|
| Email |
vedasosale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surekha S Medikeri |
| Designation |
Proffessor & HOD |
| Affiliation |
RGUHS |
| Address |
Dept of RSBK,
GAMC, Bangalore
Bangalore
KARNATAKA
560009
India |
| Phone |
9449134112 |
| Fax |
|
| Email |
surekhamedikeri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vidya Sagar GV |
| Designation |
Associate Proffessor |
| Affiliation |
RGUHS Sciences |
| Address |
Dept. of Biochemistry
Kempegowda Institute of Medical Sciences,
Bangalore
Bangalore
KARNATAKA
560070
India |
| Phone |
9880007900 |
| Fax |
|
| Email |
drgvvsagar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Veda SM |
| Address |
PG Scholar,
GAMC, Bangalore |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Veda SM |
Govt. Ayurvedic Medical College & Hospital (GAMC), Bangalore |
Room No. 7D,
Department of RSBK
Bangalore
KARNATAKA |
8762532179
vedasosale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GAMC Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashada Bhasma, Reference: Rasatarangini, Route: Oral, Dosage Form: Bhasma, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers from both genders aged between 20 to 40 years, free of any ailments and doing routine activities. |
|
| ExclusionCriteria |
| Details |
1. Any subjects with diseases / disorders.
2. Pregnancy and lactation,
3. Sports persons,
4. physical exercising,
5. mental disorders,
6. alcoholics and drug abuse.
7. Consumption of zinc supplements. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Zinc level at different intervals. Zinc levels in serum increases gradually, reaches peak and declines. |
0, 1st hr, 2nd hr, 3rd hr, 4th hr, 5th hr, 6th hr, 7th hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood Pressure before and after supplementation of Yashada Bhasma. |
0hr and after 7th Hr. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
08/09/2022 |
| 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="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will comprise of 20 healthy volunteers aged between 20 – 40 years after a written informed consent. The blood samples will be collected at 0, 1, 2, 3, 4, 5, 6 and 7 hours of supplementing 250 mg of Yashada bhasma. Serum Zinc levels are estimated with the above samples.
|