| CTRI Number |
CTRI/2020/07/026558 [Registered on: 14/07/2020] Trial Registered Prospectively |
| Last Modified On: |
07/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of a drug shadangapaniya and hot water along with kapalbhati in patients with high cholesterol and triglyceride |
|
Scientific Title of Study
|
Clinical evaluation of role of shadangapaniya and ushnodaka along with kapalbhati in daily regimen to combat medodushti wsr to dyslipidemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aakanksha sharma |
| Designation |
MD scholar |
| Affiliation |
UCA Dsrrau jodhpur, karwar |
| Address |
UCA Dsrrau jodhpur, karwar
UCA jodhpur, karwar department of swasthvritta
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9024197881 |
| Fax |
|
| Email |
vijayaakanksha1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRAMOD KUMAR MISHRA |
| Designation |
HOD |
| Affiliation |
UCA Dsrrau jodhpur, karwar |
| Address |
UCA Dsrrau jodhpur, karwar
UCA jodhpur, karwar department of swasthvritta
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9001009793 |
| Fax |
|
| Email |
Drpramodmishra4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PRAMOD KUMAR MISHRA |
| Designation |
HOD |
| Affiliation |
UCA Dsrrau jodhpur, karwar |
| Address |
UCA Dsrrau jodhpur, karwar
UCA jodhpur, karwar pg department of swasthvritta
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9001009793 |
| Fax |
|
| Email |
Drpramodmishra4@gmail.com |
|
|
Source of Monetary or Material Support
|
| UCA DSRRAU jodhpur pg department of swasthvritta |
|
|
Primary Sponsor
|
| Name |
UCA Dsrrau jodhpur karwar |
| Address |
UCA Dsrrau jodhpur, karwar |
| Type of Sponsor |
Government medical college |
|
|
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 Pramod kumar mishra |
Hospital of university college of ayurveda |
UCA DSRRAU jodhpur pg department of swasthvritta
Jodhpur
RAJASTHAN |
9001009793
drpramodmishra4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional ethics committee DSRRAU jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Shadangpaniya Kapalbhati
|
Shadangpaniya As per thirst(approx 3 litters in a day) along with Kapalbhati (3 rounds of 30 repetitions, twice a day) for 45 days
|
| Comparator Agent |
ushnodaka and kapalbhati |
Ushnodaka As per thirst (approx 3 litters in a day)along with Kapalbhati (3 rounds of 30 repititions, twice a day) for 45 days
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults of either sex 30-60 years of age
Patients with a diagnosis of non-familial hypercholesterolemia or mixed dyslipidemia as one of the following
Triglycerides between 150 mg/dl -500 mg/dl
Cholesterol between 160 mg/dl-250 mg/dl
LDL-C > 130 mg/dl
|
|
| ExclusionCriteria |
| Details |
Children and adolescents with any of the following
Known dyslipidemia
Diagnosis associated with secondary dyslipidemia
Established family history of Familial Hypercholesterolemia
Monogenic dyslipidemia other than Familial Hypercholesterolemia
Multifactorial dyslipidemia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the sign and symptoms of patients |
1 month 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of treatment |
1 month 15 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
05/08/2020 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized parallel active control trial of 45 patients in which 15 patients will be given Shadangpaniya (when patient feel thirst/As per thirst) along with Kapalbhati (3 rounds of 30 repititions, twice a day) for 45 days. 15 patients of dyslipidemia will be given ushnodaka in the quantity of 3 litters (as per thirst) along with kapalbhati (3 rounds of 30 repititions, twice a day) for 45 days and 15 patients will be treated with yogik kriya kapalbhati for 45 days
|