| CTRI Number |
CTRI/2024/07/071746 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Pippali churna in Dyslipidemia |
|
Scientific Title of Study
|
A Randomised Control Clinical Trial To Evaluate The Effect Of Pippali Churna In 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 SWATHI S L |
| Designation |
PhD Scholar |
| Affiliation |
G J Patel Institute of Ayurvedic Studies and Research Centre |
| Address |
Department of Kayachikitsa-G J Patel Institute of Ayurvedic Studies and Research studies.
Anand
GUJARAT
388121
India |
| Phone |
7034165683 |
| Fax |
|
| Email |
swathisathyan1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manchak V Kendre |
| Designation |
Professor & HOD |
| Affiliation |
G J Patel Institute of Ayurvedic Studies and Research Centre |
| Address |
Department of Kayachikitsa-G J Patel Institute of Ayurvedic studies and Research centre.
Anand
GUJARAT
388121
India |
| Phone |
9429200112 |
| Fax |
|
| Email |
manchak.kendre@cvmu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manchak V Kendre |
| Designation |
Professor & HOD |
| Affiliation |
G J Patel Institute of Ayurvedic Studies and Research Centre |
| Address |
Department of Kayachikitsa-G J Patel Institute of Ayurvedic Studies and Research centre.
Anand
GUJARAT
388121
India |
| Phone |
9429200112 |
| Fax |
|
| Email |
manchak.kendre@cvmu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
G J Patel Institute of Ayurvedic Studies and Research Centre |
| Address |
Department of Kayachikitsa ,G J Patel Institute of Ayurvedic studies and Research centre |
| Type of Sponsor |
Private 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 SWATHI S L |
S G Patel Ayurveda Hospital and maternity home |
Room number 14,Kayachikitsa OPD,S G Patel Ayurveda Hospital and Maternity home
Anand
GUJARAT |
7034165683
-
swathisathyan1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL(HUMAN)ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PIPPALI, Reference: BHAVAPRAKASHA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 24(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: MADHU), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: AMLAKI CHURNA, Reference: BHAVAPRAKASHA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 24(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: MADHU), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
• Subjects willing to give written consent and anticipated ability to attend the scheduled visits.
• Subjects those who have cholesterol levels at risk (Borderline High) selected for the study.
Total Cholesterol: 200-239mg/dl,
LDL Cholesterol: 100-159mg/dl,
HDL Cholesterol: 40-59mg/dl male ,50-59mg/dl female
Triglycerides : 150-199mg/dl
|
|
| ExclusionCriteria |
| Details |
ï¶ Subjects those who have cholesterol levels at Dangerous not selected for the study.
Total Cholesterol 240mg/dl and Higher ,LDL Cholesterol 160 mg/dl Higher HDL Cholesterol lees than40 mg/dl males,
Less than 50mg/dl female Triglyceride-200 mg/ dl and Higher
Subjects with any other acute or chronic systemic illness or infection.
Dyslipidemia associated with Obesity or Diabetes.
Pitta predominant Prakruti subjects.
Pregnant and Lactating women.
Subjects taking anti-cholesterol drugs(Both Ayurvedic and modern drugs)
Known cases of Acid Peptic Disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome: Pippali churna can make positive impact on Dyslipidemia.
|
90 DAYS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pippali Churna can make positive impact on weight & BMI of the participants |
90 DAYS |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/08/2024 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a group of plasma lipid and lipoprotein abnormality that is metabolically associated, and it is categorized by low HDL-C and increased LDL-C, TGs, and total cholesterol (TC) levels. Dyslipidemia is one of the commonest presentation and major cause for various lifestyle disorders like cardiovascular diseases, pancreatitis, fatty liver, and many other diseases. In India, there has been an alarming increase in the prevalence of CVD over the past two decades that accounts for 24% of all deaths among adults aged 25–69 years. Prevalence of Dyslipidemia according to Indian Council of Medical Research (ICMR) Integrated Disease Surveillance varies from 10-15% in rural to 25-30% in urban populations.Worldwide, these diseases are now one of the most common causes of death. Dyslipidemia accounts for about 4.40 million global death and 98.62 million disabilities in 2019, which causes a big burden to medical system..†So, this Study intends to find out the efficacy of pippali churna in dyslipidemia.One study in rats has been conducted in pippali with respect to Hyperlipidemia. That is “Effect of piperine in the regulation of obesity-induced dyslipidemia in high-fat Diet rats and the results was positive with significant reduction in total cholesterol and LDL and improvement in HDL level. But There is no clinical study has been done in Pippali churna with respect to Dyslipidemia till now in human subjects.
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