| CTRI Number |
CTRI/2019/07/020460 [Registered on: 31/07/2019] Trial Registered Prospectively |
| Last Modified On: |
12/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to to study the effect of sukshmaeladi choorna in patients with high cholesterol levels |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the effect of Sookshma Eladi choornam in Hyperlipidaemias |
| Trial Acronym |
RASH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harinatha Chary |
| Designation |
PhD Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Parul Institue of Ayurveda
Dept.of Kayachikitsa
Dept. of Kayachikitsa,
PIA, PO LIMDA, Ta. WaghodiaParul
Vadodara
GUJARAT
391760
India |
| Phone |
9440463257 |
| Fax |
|
| Email |
drbhnchary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu R |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Parul Institue of Ayurveda
Dept. of Kayachikitsa
Waghodia
Parul Institute of Ayurveda,
Dept.of Kayachikitsa, Post. Limbda, Ta. Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9481328130 |
| Fax |
|
| Email |
manu.r260022@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Harinatha Chary |
| Designation |
PhD Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Paul Institute of Ayurveda
Department of Kayachikitsa
Waghodia
Parul Institute of Ayurveda,
Departemnt of Kayachikitsa, post Limbda, Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9440463257 |
| Fax |
|
| Email |
drbhnchary@gmail.com |
|
|
Source of Monetary or Material Support
|
| S V Ayurvedic College and Hospital, Departemnt of Kayachikitsa, Room number 23, TTD, Tirupati |
|
|
Primary Sponsor
|
| Name |
B Harinatha chary |
| Address |
S V Ayurvedic college and Hospital, Dept.of Kayachikitsa, TTD, Tirupati |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| B Harinatha chary |
S V Ayurvedic College and Hospital |
Department of Kayachikitsa, Room no. 23, TTD, Tirupati
Chittoor
ANDHRA PRADESH |
9440463257
drbhnchary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIA-IECHR |
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 |
Sukshma eladi choornam
Atorvastatin
|
Sukshma eladi choornam 3 grams twice orally for 3 months
Atorvastatin orally for 3 months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group between 30 years and 70.
Patients of either gender. (Females not on oestrogen therapy)
Patients with HTN, DM and Obesity
|
|
| ExclusionCriteria |
| Details |
Hyperlipidaemias due to
1.Genetic causes
2.Thyroid abnormalities
5.Alcohol abuse
4.familial hypercholesterolemia
5. Significant hepatic or renal function test abnormalities
6.Drug intake : Corticosteroids, Diuretics, Beta-blockers, Oral contraceptives, Cyclosporin, Androgens & Retinoids |
|
|
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 |
| Lipid profile |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BMI |
90 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/08/2019 |
| Date of Study Completion (India) |
23/07/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Article titled "A critical review on Hyperlipidaemias from Ayurvedic perspective" published in WJPR,Vol 8, issue 13, 2019
2. A Pharmacognostical and Phytochemical study of Sookshma Eladi Choornam - International Journal of Ayurvedic Medicine, Vol 11 (4), 712-715
3. “A PILOT STUDY ON THE EFFICACY OF SOOKSHMA ELADI CHOORNAM IN TREATING HYPERLIPIDAEMIA†- Jan 2021. IAJPS 2021, 08 (1),1535-1539
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a randomized controlled trial comparing the safety and efficacy of Sookshma Eladi choornam 3 grm BID orally and Atorvastatin orally for 3 months in 100 patients of Hyperlipidaemias. The study was completed on 23-7-2020. Total number of dropouts in the study were 5 patients. The observations and results were obtained. Statistical analysis done. |