| CTRI Number |
CTRI/2024/02/063062 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of Trikatu Churna and Trimada Churna in Pulmonary Function Test variation in Obese Patients |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Effect of Trikatu Choorna and Trimada Choorna in the Sthoulya With Special Reference to Pulmonary Function Test and Lipid Profile |
| 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 Shruti Hiremath |
| Designation |
Assistant Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre |
| Address |
Department of Kriya Shareera, Room number 7, BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Vidya Nagar Bagalkot road Vijayapur
Dr Shruti Hiremath Assistant Professor Department of Kriya Shareera, Room number 7, BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapura 586109, KARNATAKA INDIA
Bijapur
KARNATAKA
586109
India |
| Phone |
9986970693 |
| Fax |
|
| Email |
Shrutih2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Hiremath |
| Designation |
Assistant Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre |
| Address |
Department of Kriya Shareera, Room number 7, BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapura 586109, KARNATAKA INDIA
Dr Shruti Hiremath Assistant Professor Department of Kriya Shareera, Room number 7, BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapura 586109, KARNATAKA INDIA
Bijapur
KARNATAKA
586109
India |
| Phone |
9986970693 |
| Fax |
|
| Email |
Shrutih2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Hiremath |
| Designation |
Assistant Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre |
| Address |
Department of Kriya Shareera, Room number 7, BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapura 586109, KARNATAKA INDIA
Dr Shruti Hiremath Assistant Professor Department of Kriya Shareera, Room number 7, BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapura 586109, KARNATAKA INDIA
Bijapur
KARNATAKA
586109
India |
| Phone |
9986970693 |
| Fax |
|
| Email |
Shrutih2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Room Number 7, Vidya Nagar, Bagalkot Road Vijayapura- 586109 |
|
|
Primary Sponsor
|
| Name |
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA BANGALORE |
| Address |
Advance Research wing 4th T block Jayanagar Bangaluru 560041 |
| Type of Sponsor |
Government funding agency |
|
|
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 Shruti Hiremath |
BLDEAs avs ayurveda mahavidyalaya Hospital and Research Centre |
Department of Kriya Shareera, Room Number 7, BLDEAs avs ayurveda mahavidyalaya Hospital and Research Centre Vidya Nagar, Bagalkot road Vijayapura -586109
Bijapur
KARNATAKA |
9986970693
Shrutih2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDEAs AVS Ayurveda Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E668||Other obesity. Ayurveda Condition: Sthoulya, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trikatu choorna, Reference: Bhaishajya Ratnavali 4/16, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trimada Choorna, Reference: Bhaishajya Ratnavali 4/18, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Patients diagnosed with clinical features of Sthoulya.
• Body mass index should be more than 30.
• Subjects signed on informed consent form.
|
|
| ExclusionCriteria |
| Details |
• Diagnosed with respiratory disorders.
• Cardiac diseases
• Diabetics and Hypertension.
• Abnormal chest wall, Shape, Size
• History of renal dysfunction.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Criteria:
Symptoms mentioned in the Ayurvedic classical texts.
• Shrama (Exhaustion)
• Alpe ApiChestiteShwasam(Dyspnea/difficulty in breathing even with minimal strain)
• Spik Lambanam(sagging of buttocks),
• StananLambanam(Sagging of Breasts),
• Udara Lambanam(Sagging of abdomen).
Objective criteria
• Anthropometricmeasurements-BMI, Waist hip circumference, Skin fold thickness
• Pulmonary function test- Spirometry- To get the Pulmonary functionParameters like Residual Volume, Functional Residual volume, Tidal Volume, FEV1(Forced Expiratory Volume), FVC (Forced Vital Capacity), FEV1/FVC ratio, PEFR (Peak Expiratory Flow rate), MVV (Maximum Voluntary Ventilation).
• Lipid profile |
Patient is assessed with the above said parameters on 90th day. The observation will be recorded in the proforma of case sheet. Follow up will be done after 1mn. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know the effect of Trikatu choorna and Trimada choorna in sthoulya and observe any changes in PFT and Lipid Profile. |
Patient is assessed with the above said parameters on 90th day. The observation will be recorded in the proforma of case sheet. Follow up will be done after 1mn. |
|
|
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)
|
29/04/2024 |
| 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="0"
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
|
This is a comparative clinical study which is carried out in two groups and each group carries 30 patients. Group A - Trikatu Choorna and Group B - Trimada Choorna. PFT and Lipid Profile is assessed before and after the intervention. Patients who visit BLDEAs AVS AMV Hospital IPD and OPD are randomly selected who fits in the inclusion criteria. The diagnosed subject of Sthoulya will be evaluated by a detailed history and clinical examinations. From this study we can evaluate the variations of the Pulmonary function and lipid profile in sthoulya subjects and to find the association between them. Also to evaluate the effect of Trikatu Choorna and Trimada Choorna on both Pulmonary function test and Lipid Profile in Sthoulya with clinicla trial. |