| CTRI Number |
CTRI/2022/12/047928 [Registered on: 07/12/2022] Trial Registered Prospectively |
| Last Modified On: |
06/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of seasonal Haritaki use in Dyslipidemia in winter season |
|
Scientific Title of Study
|
A randomised controlled clinical trial to evaluate the efficacy of rutu Haritaki in Dyslipidemia in Shishir rutu |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepali Manore |
| Designation |
PhD Scholar |
| Affiliation |
PDEAs College of Ayurved & Research centre Nigdi Pune |
| Address |
Swasthyarakshan Department 123B,Ayurved Rugnalaya and Sterling multispeciality Hospital,Sector 27,Nigdi ,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9881650526 |
| Fax |
|
| Email |
dr.manore@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R B Bobade |
| Designation |
Professor & HOD |
| Affiliation |
PDEAs College of Ayurved & Research centre Nigdi Pune |
| Address |
Swasthyarakshan Department 123B,Ayurved Rugnalaya and Sterling multispeciality Hospital,Sector 27,Nigdi ,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9403928005 |
| Fax |
|
| Email |
rajkumarbobade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R B Bobade |
| Designation |
Professor |
| Affiliation |
PDEAs College of Ayurved & Research centre Nigdi Pune |
| Address |
Swasthyarakshan Department 123B,Ayurved Rugnalaya and Sterling multispeciality Hospital,Sector 27,Nigdi ,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9403928005 |
| Fax |
|
| Email |
rajkumarbobade@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College Of Ayured and Research Centre Nigdi Pune |
|
|
Primary Sponsor
|
| Name |
PDEAS College of Ayurved and Research centre |
| Address |
Sector 25 Nigdi Pradhikaran Pune 411044 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrManore DJ |
Ayurved Rugnalaya & Sterling Multispeciality Hospital |
Sect.27,Nigdi Pradhikaran,Pune 411044
Pune
MAHARASHTRA |
9881650526
dr.manore@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rutu Haritaki, Reference: Bhavpraksha Smhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Pippali), Additional Information: Drug will be given for 2 months | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haritaki, Reference: Bhavprakash, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: Drug will be given for 2 months |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients in age group 40 to 60 years, either male or female, irrespective of occupation & Patients who are not taking any medication for management of Dyslipidemia. Patients having alterations in lipid profile as follows will be selected |
|
| ExclusionCriteria |
| Details |
Individuals suffering from any severe systemic illness, serious acute &chronic illness
Patients with history of cardiovascular disease, Previous history of stroke, will be excluded.
Patients suffering from type 1 DM, Uncontrolled Type 2 DM, Type 2 DM patients taking insulin, diastolic Blood pressure >90 mm of Hg, Patients having history of Chronic liver & kidney Disease, Malignancy, Patients on medication with corticosteroids, diuretics will be excluded.
Pregnant & Lactating women Patients suffering from Pitta aggravation symptoms
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in levels of Cholesterol in patients of dyslipidemia |
0 days,8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BMI |
0 days,8 weeks |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 |
|
Date of First Enrollment (India)
|
09/12/2022 |
| 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="2"
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)?
Response - NO
|
|
Brief Summary
|
Elevated plasma
cholesterol levels are a major risk factor for cardiovascular diseases.
Atherosclerotic plaque formation is an inflammatory process in the endothelial
vessel wall associated with retained low-density lipoprotein (LDL). Strategies
to combat elevated cholesterol levels include lifestyle changes and
pharmacological interventions.
Drug treatment of high blood lipids is
necessary to reduce cardiovascular risk and prevent heart attacks, strokes,
high blood pressure, fatty liver disease, diabetes, among people with this
condition. To prevent & cure these diseases Rutu Haritaki can act effectively
as Rasayan by balancing vitiation of dosha. Haritaki is advocated for all
seasons along with specific Anupan in Bhavprakash Samhita to balance
physiological variations of dosha due to seasonal changes.In shishir rutu s
accumulation of Kapha dosha takes place.
Acharya Bhavamishra stated that Haritaki should
be taken with the adjuvant Pippali in Shishir Rutu. Pippali pacifies
kaphadosha. Haritiki & Pippali both pacifies kapha Vata dosha. Thus
Haritaki along with Pippali in Shishir Rutu maintains equilibrium of tridosha.
Excessive accumulation of kapha dosha can lead to increase in Meda
dhatu. Currently available hypolipidemic drugs have been associated with a
number of side effects.Properties of Haritaki as mentioned in samhita is having
predominance of Kashaya Rasa & Ushnaveerya. Due to these properties it
causes reduction in Medodushti. Hence Haritaki can be used to reduce
dyslipidemia. Hence this study is selected.
Patient with abnormal lipid profile and aged
between 40 to 60 years will be selected. Study drug & control Drug will be
provided to the patient in two groups for 60 days. Assessment will be done by
subjective & objective parameters. Analysis will be done. Conclusion will
be drawn.
|