| CTRI Number |
CTRI/2025/04/085253 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical study to know the benefit of Dashanga Guggulu and Navaka Guggulu in obesity With Reference to Hyperlipidaemia. |
|
Scientific Title of Study
|
A Comparative Clinical Study of Dashanga Guggulu and Navaka Guggulu in the Management of Sthoulya With Special Reference to Hyperlipidaemia. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrBhagyashree |
| Designation |
PG scholar |
| Affiliation |
Sri Shivayoogeeshwara ayurvedic medical College inchal belgaum dist soundatti taluk |
| Address |
Department of kayachikitsa 1st floor Department of kayachikitsa Shri Shivayogeeshwara rural ayurvedic medical College inchal belgaum dist soundatti tq
Belgaum
KARNATAKA
591102
India |
| Phone |
7022020472 |
| Fax |
|
| Email |
bhagyaveeru99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ishwarayya s matapati |
| Designation |
Professor |
| Affiliation |
Shri Shivayoogeeshwara rural ayurvedic medical College inchal belgaum dist soundatti taluk |
| Address |
Shri Shivayoogeeshwara rural ayurvedic medical College inchal belgaum dist soundatti tq
Belgaum
KARNATAKA
591102
India |
| Phone |
7259779463 |
| Fax |
|
| Email |
dr.ishwar.mathapati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagyashree |
| Designation |
PG Scholar |
| Affiliation |
Shri Shivayoogeeshwara rural ayurvedic medical College inchal belgaum dist soundatti tq |
| Address |
Shri Shivayoogeeshwara rural ayurvedic medical College inchal belgaum dist soundatti tq
Belgaum
KARNATAKA
591102
India |
| Phone |
7022020472 |
| Fax |
|
| Email |
bhagyaveeru99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Shivayoogeeshwara rural ayurvedic medical College and hospital inchal belgaum dist soundatti tq
Karnataka,
Pincode -591102
India |
|
|
Primary Sponsor
|
| Name |
DrBhagyashree |
| Address |
Shri Shivayogeeshwara Rural Ayurvedic Medical College and Hospital Inchal Belgaum dist Saundatti Taluk
karnataka
591102
India |
| 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 |
| DrBhagyashree |
Shri Shivayoogeeshwara rural ayurvedic medicine college inchal |
1st floor Department of kayachikitsa ,Shri Shivayoogeeshwara rural ayurvedic medical College & hospital inchal belgaum dist soundatti tq
Karnataka
591102
Belgaum
KARNATAKA |
7022020472
bhagyaveeru99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Shivayoogeeshwara rural ayurvedic medical College inchal belgaum dist soundatti tq |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashanga Guggulu , Reference: Bhavaprakasha, medorogadikara , Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: -ushnajala ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navaka Guggulu , Reference: Bhaishajya ratnavali medoroga chikitsa 39/43, Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: -ushnajala ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
subjects of either gender presenting with clinical features of sthoulya according to Ayurveda
BMI more than or equal to 25kg/m2 to 35kg/m2
after taking consent from the subjects
|
|
| ExclusionCriteria |
| Details |
any systemic diseases that inteerfere with the course of treatment
pregnant and lactating women
obesity produced due to certain secondary causes such as hereditary hormonal changes will also be excluded |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A multi dimensional scoring pattern will be adopted for the sign and
symptoms of sthaulya mentioned in Ayurvedic texts like
Chalatva of speak stana udara (Movement of hip abdomen and breast)
Swedadhikya (Excessive sweating)
Daurgandhya (Bad body odours)
Atikshudha (Excessive hunger)
Atipipasa (Excessive thirst)
Nidradhikya(Excessive sleeping)
Kshudraswasa(dyspnea) |
After 21day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptoms of Sthoulya mentioned in ayurveda in 1st visit are got reduced and some changes in the weight are seen |
After 40 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
17/05/2025 |
| 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="1"
Months="0"
Days="0" |
|
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
|
It is a comparative clinical study to evaluate the effectiveness of Dashanga Guggulu and Navaka Guggulu in patients of Sthoulya with a special reference to Hyperlipidaemia , total 40 number of subjects are divided into 2 groups and for each group different type of medicine is administered from above mentioned drugs internally with a dose of 1000mg(2tab) twice daily after food with a lukewarm water as a anupana along with lifestyle modification. Assessment parameters like chala sphik,udara,stanalambana,Atisweda,Atikshudha,Atitrishna,Nidradikya(atinidra)& kshudrashwasa as subjective parameters and Body weight,BMI(body mass index),Girth circumference of chest , abdomen, waist,hip using measuring tape and lipid profile as objective parameters are observed on 21st day and 41th day at kayachikitsa opd,Shri Shivayoogeeshwara rural ayurvedic medical College and hospital inchal.
|