| CTRI Number |
CTRI/2025/07/091002 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study Of Kulattha Seed Powder In increased cholesterol levels to prevent cardiovascular diseases |
|
Scientific Title of Study
|
Evaluation and Clinical Study Of Kulattha Dolichos biflorus linn on Medovriddhi wsr Hyperlipidemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parul Saini |
| Designation |
PG Scholar |
| Affiliation |
Sri Ganganagar College of Ayurvedic Science and Hospital |
| Address |
Department Of Dravyaguna Vigyan Sri Ganganagar College of Ayurvedic Science and Hospital Tantia University Riico Sri Ganganagar 335002
Department Of Dravyaguna Vigyan Sri Ganganagar College of Ayurvedic Science and Hospital Tantia University Riico Sri Ganganagar 335002
Ganganagar
RAJASTHAN
335002
India |
| Phone |
8266936367 |
| Fax |
2494125 |
| Email |
sainiparul888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Omprakash Sharma |
| Designation |
HOD Dravyaguna Vigyan |
| Affiliation |
Sri Ganganagar College of Ayurvedic Science and Hospital |
| Address |
Department of Dravyagun Vigyan Sri Ganganagar College of Ayurvedic Science and Hospital Tantia University Riico Sri Ganganagar 335002
Department Of Dravyagun Vigyan Sri Ganganagar College of Ayurvedic Science and Hospital Tantia University Riico Sri Ganganagar 335002
Ganganagar
RAJASTHAN
335002
India |
| Phone |
9414248057 |
| Fax |
2494125 |
| Email |
dr.opsarswat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parul Saini |
| Designation |
PG Scholar |
| Affiliation |
Sri Ganganagar College of Ayurvedic Science and Hospital |
| Address |
Department of Dravyaguna Vigyan Sri Ganganagar College of Ayurvedic Science and Hospital Tantia University Riico Sri Ganganagar 335002
Department Of Dravyaguna Vigyan Sri Ganganagar College of Ayurvedic Science and Hospital Tantia University Riico Sri Ganganagar 335002
Ganganagar
RAJASTHAN
335002
India |
| Phone |
8266936367 |
| Fax |
2494125 |
| Email |
sainiparul888@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Parul Saini |
| Address |
Sri Ganganagar College of Ayurvedic Science and Hospital Tantia University Riico Sri Ganganagar 335002 |
| 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 |
| Dr Parul Saini |
Sriganganagar College Of Ayurvedic Science And Hospital |
Department Of Dravyaguna Vigyan
Ganganagar
RAJASTHAN |
8266936367
sainiparul888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Kulattha beej churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 01(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 02 Months, anupAna/sahapAna: Yes(details: Ushna Jal), Additional Information: NA |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
all subjects with visible sign and symptoms of hyperlipidemia between the age of 30 to 60 years of age |
|
| ExclusionCriteria |
| Details |
Patient With Underlaying Morbid Disease |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lipid Profile Result Correction And To Prevent Cardiovascular Disease |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This Trial Will Conclude The Hypolipidemic Activity Of Kulattha Described In Ayurveda And It Will Evaluate The Efficacy Of Hypolipidemic Action Of Kulattha On Internal Use |