| CTRI Number |
CTRI/2020/01/022906 [Registered on: 21/01/2020] Trial Registered Prospectively |
| Last Modified On: |
29/03/2021 |
| 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
|
Ayurvedic management of high cholesterol and triglycerides- A clinical study |
|
Scientific Title of Study
|
AN OPEN-LABELLED RANDOMIZED CONTROLLED PARALLEL GROUP CLINICAL STUDY TO EVALUATE THE EFFICACY OF GUDUCHYADI CHURNA IN THE MANAGEMENT OF MEDOROGA W.S.R DYSLIPIDEMIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parvathy B |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room no-304, Department of kayachikitsa
Sri Sri College of Ayurvedic Science and Research
21stkm, Kanakapura Road,
Udayapura PO, Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9148002571 |
| Fax |
|
| Email |
parvathyb14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelakanta J Sajjanar |
| Designation |
Assosciate proffessor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room no-304, Department of kayachikitsa
Sri Sri College of Ayurvedic Science and Research
21stkm, Kanakapura Road,
Udayapura PO, Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9844812331 |
| Fax |
|
| Email |
neelkant.ayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parvathy B |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room no-304, Department of kayachikitsa
Sri Sri College of Ayurvedic Science and Research
21stkm, Kanakapura Road,
Udayapura PO, Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9148002571 |
| Fax |
|
| Email |
parvathyb14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic science and Research Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Parvathy B |
| Address |
PG Scholar
Room no-304, Department of Kayachikitsa
Sri Sri College of Ayurvedic science and Research
21stkm, Kanakapura road, Udayapura PO, Bangalore |
| Type of Sponsor |
Other [] |
|
|
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 Parvathy B |
Sri Sri College of Ayurvedic science and Research Hospital |
Room no-05, Department of Kayacikitsa, Sri Sri College of Ayurvedic science and Research Hoapital,
21stkm, Kanakapura road, Udayapura PO, Bangalore
Bangalore
KARNATAKA |
9148002571
parvathyb14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
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 |
Guduchyadi churna |
Guduchyadi churna is a combination of churnas of guduchi, haritaki and musta in equal parts. Dosage- 6gms for churna twice daily for 1 month. |
| Comparator Agent |
Navaka Guggulu |
Navaka guggulu is a polyherbal formulation containing 9 ingredients. They are Shunti, Maricha, Pippali, Haritaki, Amlaki, Vibhitaki, Musta, Vidanga & Guggulu. Dosage- 2 tablets twice daily for 1 month. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with increased level of any of the serum lipids, such as serum cholesterol(200-350mg/dl), serum triglycerides (150- 400mg/dl), serum low density lipoproteins (LDL) (130-250mg/dl), serum very low-density lipoprotein (40-150mg/dl), diagnosed cases and fresh cases will be included. Patients taking Lipid lowering medications will be included for the study after a wash out period of 15 days after the stoppage of medicines. Both obese and non-obese patients will be included. Subjects willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with uncontrolled major systemic disorders, patients with HbA1c above 8 % (HPLC method) or above 9% (IEC method), patients with TSH levels above 5.0 mU/L, pregnant & lactating women |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the levels of Total cholesterol, LDL, VLDL, Triglycerides. |
30th day, 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the classical lakshanas of Medoroga |
30th day, 60th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/01/2020 |
| 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="1"
Months="0"
Days="0" |
|
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
Modification(s)
|
This study is put forward to evaluate the efficacy of Guduchyadi churna on the samprapti of medoroga w.s.r dyslipidemia in comparison to Navaka guggulu. Hypothesis: Null hypothesis-H0: The efficacy of Guduchyadi churna is equivalent to the efficacy of Navaka guggulu in the management of medoroga w.s.r dyslipidemia. Research hypothesis-H1: The efficacy of Guduchyadi churna is not equivalent to the efficacy of Navaka guggulu in the management of medoroga w.s.r dyslipidemia.
|