| CTRI Number |
CTRI/2021/12/038393 [Registered on: 02/12/2021] Trial Registered Prospectively |
| Last Modified On: |
01/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative Clinical study on the effect of Arjuna-RasonÄdi yoga & Navaka guggulu On Medodushti |
|
Scientific Title of Study
|
An Open Labelled, Randomized, Comparative Study Of Arjuna-Rasonadi yoga & Navaka guggulu On Medodushti With Special Reference To Dyslipidaemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Kumar |
| Designation |
M.D Scholar |
| Affiliation |
National Institute Of Ayurveda |
| Address |
PG Dept. of Rog Nidaan evam Vikriti Vigyan,NIA,Amer Road, Madhav Vilas JAIPUR.
Jaipur
RAJASTHAN
302002
India |
| Phone |
09413220802 |
| Fax |
|
| Email |
ravindra.v.dheeraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reetu Sharma |
| Designation |
Senior Assistant professor |
| Affiliation |
National Institute Of Ayurveda |
| Address |
PG Dept. of Rog Nidaan evam Vikriti Vigyan,national institute of ayurveda, Amer Road, Madhav Vilas, JAIPUR.
Jaipur
RAJASTHAN
302002
India |
| Phone |
8368960978 |
| Fax |
|
| Email |
drreetusharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reetu Sharma |
| Designation |
Senior Assistant professor |
| Affiliation |
National Institute Of Ayurveda |
| Address |
PG Dept. of Rog Nidaan evam Vikriti Vigyan,national institute of ayurveda, Amer Road, Madhav Vilas jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
8368960978 |
| Fax |
|
| Email |
drreetusharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF AYURVEDA (DU)JAIPUR |
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayurveda deemed to be universityjaipur |
| Address |
National institute of Ayurveda deemed to be university (De Novo) ,Madhav Vilas Palace, Amer Road Jaipur 302002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravindra Kumar |
National Institute of Ayurveda HOSPITAL, Jaipur |
Room no.OPD 17,rog nidan department OPD,National institute of Ayurveda,jaipur
Jaipur
RAJASTHAN |
09413220802
ravindra.v.dheeraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navaka gugulu, Reference: Chakardatta, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Arjunrasonadi yoga, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Willing to give written informed consent and willing to comply with trial protocol.
2 Subjects in the age group of 18–70 years of both genders.
3 As per ATP III guidelines; baseline LDL ranging 160- 189mg/dl, TC ≥200 mg/dL, TG ranging 150-199 mg/dL.
4 Ability to understand the risks or benefits of the protocol.
5 Subject should be available for duration of study period.
|
|
| ExclusionCriteria |
| Details |
1 Participants with chronic diseases requiring continuous use of vasoactive drugs, diuretics, lipid-lowering or anti-diabetic drugs.
2 Subjects having history of diabetes (Type I or Type II) except other than the subject having the prediabetes condition with the random blood glucose 140-199 mg/dl.
3 Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain.
4 Subjects having history of serious cardiovascular diseases such MI.
5 Subjects having abnormal liver (ALT or AST) 2 times the upper limit of normal;
6 Subjects having abnormal findings on complete blood count.
7 Subjects having history of high alcohol intake (2 standard drinks per day).
8 Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
9 Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
10 Subjects participated in any other clinical trials within thirty (30) days prior to screening.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the levels at Day 60 from the baseline in:
1.Lipid Profile (Total cholesterol, HDL, LDL, VLDL & TGL)
|
Change in the levels at Day 60 from the baseline in:
1.Lipid Profile (Total cholesterol, HDL, LDL, VLDL & TGL)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in the levels at Day 60 from the baseline in:
1 Total Cholesterol/ HDL ratio
2 Changes in Blood Pressure ((BP) from baseline till 60th Day visit
|
Change in the levels at Day 60 from the baseline in:
1 Total Cholesterol/ HDL ratio
2 Changes in Blood Pressure ((BP) from baseline till 60th Day visit
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
03/12/2021 |
| 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="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)?
|
|
Brief Summary
|
Recruitment and selection of patients: - Patients attending OPD, IPD of NIA and satisfying the selection criteria will be selected. All patients who voluntarily agree to participate and provide written informed consent for participation will be recruited in the study. During the study period, there will be 4 visits including the Screening visit. Screening visit 1 (Day (-3 to day 0): - Study discussions, pre- screening, ID proof verification & collection, and registration of subjects, Informed Consent, Medical History, physical examination, Concomitant Medication, Concurrent Illness, Complete blood count with ESR, RBS, Lipid Profile (Total Cholesterol, HDL, LDL, VLDL, Triglycerides), Liver Function Tests (Bilirubin-Direct & Total, Albumin, SGOT, SGPT, ALP) will be done. Visit 2 (Recruitment) (Day 1): - The eligibility of the subject will be assessed. Eligible subjects will be called for Physical examination and vital signs will be recorded. concomitant medication, concurrent illness will be recorded. Visit 3 (Day 30 ± 3): - Physical examination will be done and vital signs will be recorded. Study medication will be dispensed to the subject for 30 days. History of concomitant medication, concurrent illness, AE information if any, compliance to treatment will be assessed and documented in the CRF. Visit 4 (Day 60 ± 3): - Physical examination of the subject will be done and vital signs will be recorded. history of concomitant medication, adverse events if any, Concurrent Illness, Blood Pressure, Complete blood count with ESR, Lipid Profile, Liver Function Tests. compliance to treatment will be assessed and documented in the case record for (CRF). |