| CTRI Number |
CTRI/2023/11/059944 [Registered on: 17/11/2023] Trial Registered Prospectively |
| Last Modified On: |
14/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of trayushnadi guggulu in patients of sthoulya |
|
Scientific Title of Study
|
RANDOMISED OPEN LABLED CONTROLLED CLINICAL TRIAL STUDY TO ASSESS THE EFFICACY OF TRAYUSHNADI GUGGULU IN MANAGEMENT OF STHAULYA W.S.R TO VISCERAL FAT AND HYPERLIPIDEMIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya narayan kashid |
| Designation |
PG scholar |
| Affiliation |
Siddhakala ayurved mahavidyalay, sangamner |
| Address |
OPD number 1 Kaychikitsa department Siddhakala ayurved mahavidyalay, pimparne road, sangamner
Kaychikitsa OPD 1 Siddhakala ayurved mahavidyalay, pimparne road, sangamner
Ahmadnagar
MAHARASHTRA
431122
India |
| Phone |
8208463754 |
| Fax |
|
| Email |
aishwaryakashid43608@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VdOmkar kortikar |
| Designation |
Head of department of Kaychikitsa |
| Affiliation |
Siddhakala ayurved mahavidyalay, sangamner |
| Address |
Kaychikitsa department Siddhakala ayurved mahavidyalay sangamner
Siddhakala ayurved mahavidyalay pimparne road sangamner
Ahmadnagar
MAHARASHTRA
415609
India |
| Phone |
9850218004 |
| Fax |
|
| Email |
Omkar_kortikar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
VdOmkar kortikar |
| Designation |
BAMS MD |
| Affiliation |
Siddhakala ayurved mahavidyalay, sangamner |
| Address |
Kaychikitsa department Siddhakala ayurved mahavidyalay pimparne road sangamner
Siddhakala ayurved mahavidyalay, pimparne road, sangamner
Ahmadnagar
MAHARASHTRA
415609
India |
| Phone |
9850218004 |
| Fax |
|
| Email |
Omkar_kortikar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala ayurved mahavidyalay pimparne road sangamner khurda |
|
|
Primary Sponsor
|
| Name |
Aishwarya kashid |
| Address |
Siddhakala ayurved mahavidyalay, sangamner |
| Type of Sponsor |
Other [Own] |
|
|
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 |
| DrAishwarya kashid |
Siddhakala ayurved mahavidyalay sangamner |
Kaychikitsa OPD of Siddhakala ayurved mahavidyalay sangamner
Ahmadnagar
MAHARASHTRA |
9146410164
aishwaryakashid43608@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board of ayurved research and statistics committee of siddhakala ayurved mahavidyalay, sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOVRUDDHIH , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trayushnadi guggulu , Reference: Bhavaprakash Samhita madhyam khanda of pandit shri Bramhashankar Mishra chaukhamba Sanskrit series , Varanasi., Route: Oral, Dosage Form: Guggulu , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: -nil | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: -nil |
|
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
cases of Sthaulya (Obesity) diagnosed according to classical features.
Patients of both sexes between 16-60 years of age.
Patients with BMI more than 25.
|
|
| ExclusionCriteria |
| Details |
patients age less than 16 years and more than 60 years.
Obesity due to secondary causes like Endocrinal disorders, CNS diseases, medications etc.
Patients having major systemic disorders or other illness which interfere with the present study. Endocrinal disorders like hypothyroidism, diabetes, etc.
Pregnant, lactating women.
Patient on prolonged medications with corticosteroids, NSAIDS, antidepressants, or any drugs that may influence on the outcome of study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study in detail the efficacy of Trayushnadi guggulu in sthaulya with special reference to visceral fat and hyperlipidemia
|
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the properties & efficacy of Trayushnadi guggulu as per mentioned in Ayurvedic Samhita.
To study Sthaulya chikitsa as per ancient Ayurveda.
To study details about visceral fat & hyperlipidemia.
|
15days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 |
|
Date of First Enrollment (India)
|
01/12/2023 |
| 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="6"
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 study is a randomized, open labelled, controlled clinical trial comparing the safety and efficacy of trayushnadi guggulu 500mg and placebo 500mg for 15days in 84 patients with sthoulya and also its effect on viseral fat and hyperlipidemia. |