| CTRI Number |
CTRI/2024/07/070151 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| 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
|
A Comparative Clinical Study of Krakashdaladi Kwath and Navaka Guggulu in the management of Medodushti with special reference to Dyslipidemia |
|
Scientific Title of Study
|
An Open Labelled Parallel Comparative Clinical Study to evaluate the efficacy of Krakashdaladi Kwath and Navaka Guggulu in the management of Medodushti with special reference to Dyslipidemia |
| 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 Charu Walia |
| Designation |
Post-graduation student |
| Affiliation |
Institute for Ayurved Studies and Research, SKAU, Kurukshetra |
| Address |
Room no. 56, Department of kayachikitsa, Institute for Ayurved Studies and Research, SKAU, Kurukshetra
Sector-8 Umri road, Kurukshetra, 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9996641775 |
| Fax |
|
| Email |
ccharuwalia98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam |
| Designation |
Professor and Chairperson |
| Affiliation |
Institute for Ayurved Studies and Research, SKAU, Kurukshetra |
| Address |
Room no. 70, Department of kayachikitsa, Institute for Ayurved Studies and Research, SKAU, Kurukshetra
Sector-8 Umri road, Kurukshetra, 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9671368058 |
| Fax |
|
| Email |
mehranilam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charu Walia |
| Designation |
Post-graduation student |
| Affiliation |
Institute for Ayurved Studies and Research, SKAU, Kurukshetra |
| Address |
Room no. 56, Department of kayachikitsa, Institute for Ayurved Studies and Research, SKAU, Kurukshetra
Sector-8 Umri road, Kurukshetra, 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9996641775 |
| Fax |
|
| Email |
ccharuwalia98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies and Research, SKAU, Sec-8, Umri road, Kurukshetra, Haryana, India, 136118 |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies and Research |
| Address |
Institute For Ayurved Studies and Research, Sec-8, Umri road, Kurukshetra,Haryana, 136118 |
| 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 charu walia |
Institute for Ayurved Studies and Research, SKAU, Kurukshetra |
Room no-56, Kayachikitsa OPD, Institute for Ayurved Studies and Research, SKAU, Sec-8, Umri road, Kurukshetra, 136118
Kurukshetra
HARYANA |
9996641775
ccharuwalia98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Krishna Ayush University Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Karkashdaladi Kwath, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navaka Guggulu, Reference: Bhaishajya kalapana, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to sign the consent form.2.Patients between the age group of 25-45 years of either gender.3.Patients having underweight, normal weight, overweight, and class I obesity according to BMI.4.Diagnosed & confirmed cases of Medodushti (Dyslipidemia) & Medoroga on the basis of criteria given by NCEP-ATPIII. (Borderline High category). |
|
| ExclusionCriteria |
| Details |
a) Patient not fulfilling inclusion criteria.
b) Patient not willing for clinical trial.
c) Patient below 25yrs of age group and above 45yrs of age group.
d) Patients having medical history of – CAD, CKD, AKD, Uncontrolled Diabetes Mellitus, Uncontrolled Hypertension.
e) Patient on steroid therapy and oral contraceptive therapy.
f) Pregnant women and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Karkashdaladi kwath and Navak guggulu by applying appropriate stastical tools in the management of dyslipidemia.
|
28 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in weight, BMI, Serum cholesterol, Serum triglycerides, LDL, VLDL, and an increase in Serum HDL.
2. Reduction in scoring pattern of sign and symptoms of Medorog |
28 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Dyslipidemia can be corelated to medodushti as
described in ayurveda. Dyslipidemia is derangement of lipids. Dyslipidemia
is highly prevalent and is one of modifiable risk factor for Diabetes mellitus,
Obesity, Chronic heart Diseases, Thyroid Disorders. Modern statins are the
medicine of choice for dyslipidemia, but they come with a long list of side
effects. Therefore, seeking safe and efficient ayurveda treatment is necessary
for a better solution. Karkashdaladi kwath has all the properties that are
useful to produce Strotovishodhana, Aamapachana and Lekhan of Meda and so has Navak Guggulu. A
study aimed at comparing the efficacy of Karkashdaladi kwath and Navak Guggulu will be
carried out on patients who will be randomly selected and divided in two groups
having 30 patients in each group.
In group A (30 patients) karkashdaladi kwath (50ml) will be given after meal with water and In group B
(30 patients) Navak guggulu (500mg) will be after meal with for 28 days. Patients
will be followed up at regular interval of 7 days during the course of therapy
to assess variation in symptomatology and to know any complication. Subjective and objective criteria
will be analysed during and post treatment. The
work will be compiled and the outcome will be drawn using statistical data.
|