| CTRI Number |
CTRI/2019/01/016990 [Registered on: 08/01/2019] Trial Registered Prospectively |
| Last Modified On: |
29/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [TREATMENT] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF GUDUCHI TRIPHALA KASHAYA WITH VIDANGADHYA LOHA AND STHOULYAHARA KASHAYA WITH VIDANGADHYA LOHA IN THE MANAGEMENT OF STHOULYA WSR TO OBESITY |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF GUDUCHI TRIPHALA KASHAYA WITH VIDANGADHYA LOHA AND STHOULYAHARA KASHAYA WITH VIDANGADHYA LOHA IN THE MANAGEMENT OF STHOULYA WSR TO OBESITY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sowmya K S |
| Designation |
PG Scholar |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre |
| Address |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
No 10 Pipeline Road Vijayanagar Bengaluru 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
7259379280 |
| Fax |
|
| Email |
sowmyasrivas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashekar CV |
| Designation |
Professor |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre |
| Address |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
No 10 Pipeline Road Vijayanagar Bengaluru 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
8867212844 |
| Fax |
|
| Email |
drrajhere@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sowmya K S |
| Designation |
PG Scholar |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre |
| Address |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
No 10 Pipeline Road Vijayanagar Bengaluru 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
7259379280 |
| Fax |
|
| Email |
sowmyasrivas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR SOWMYA K S |
| Address |
VIJAYNAGAR, BENGALURU -560104 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR RAJASHEKHAR C V |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL & RESEARCH CENTRE |
VIJAYNAGAR, BENGALURU -560104
Bangalore
KARNATAKA |
8867212844
drrajhere@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guduchi Triphala Kashaya with of Shodhita Guggulu |
24ml Of Guduchi Triphala Kashaya With 1gm Of Shodhita Guggulu In The Morning And Evening Before Food For 30 Days And Vidangadhya Loha 1 Tablet (500mg) Bd After Food For 30 Days |
| Comparator Agent |
Sthoulyahara Kashaya along with Honey |
24ml Of Sthoulyahara Kashaya Along With 6ml Honey In The Morning And Evening Before Food For 30 Days And Vidangadhya Loha 1 Tablet (500mg) Bd After Food For 30 Days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients Presenting With Lakshanas Of Sthoulya.
Patients Diagnosed As Obesity With Bmi > 30
Patients From 18 To 60 Years Of Either Sex.
Patients Who Are Not a Known Case Of Endocrine Disorders.
Patients Are Suffering Obesity With Primary Causes
Like Sedentary Life Style, Improper Diet |
|
| ExclusionCriteria |
| Details |
Any Systemic Illness That Interferes With The Course Of Intervention.
Pregnant And Lactating Women. |
|
|
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 |
| THE EFFICACY OF INTERVENTION ON SUBJECTIVE AND OBJECTIVE CRITERIA OF STHOULYA |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/01/2019 |
| Date of Study Completion (India) |
20/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
OVERWEIGHT &
OBESITY ARE THE FIFTH LEADING RISK OF GLOBAL DEATHS. THE WORLDWIDE PREVALENCE
OF OBESITY NEARLY TRIPLED BETWEEN 1975 AND 2016. GUDUCHI TRIPHALA KASHAYA MENTIONED
IN BHAVAPRAKASHA, MEDOROGADIKARA HAS INGREDIENTS GUDUCHI, TRIPHALA, GUGGULU
HAVING TIKTA RASA PRADHANA, AGNIDIPAKA, AAMAPACHAKA, KAPHA MEDOHARA PROPERTIES
AND IS RECOMMENDED FOR CHIKITSA OF STHOULYA. STHOULYAHARA KASHAYA AND
VIDANGADHYA LOHA ARE HAVING
MEDOHARA PROPERTY AND ARE INDICATED IN STHOULYA. THESE DRUGS ARE SELECTED FOR
PRESENT STUDY. 24ML OF GUDUCHI
TRIPHALA KASHAYA WITH 1GM OF SHODHITA
GUGGULU IN THE MORNING AND EVENING BEFORE FOOD FOR 30 DAYS AND VIDANGADHYA
LOHA 1 TABLET (500MG) BD AFTER FOOD FOR 30 DAYS.
24ML OF STHOULYAHARA KASHAYA ALONG
WITH 6ML HONEY IN THE MORNING AND EVENING BEFORE FOOD FOR 30 DAYS AND VIDANGADHYA
LOHA 1 TABLET (500MG) BD AFTER FOOD FOR 30 DAYS THAT WILL BE CONDUCTED IN SRI
KALABYRAWESHWARA SWAMY AYURVEDIC HOSPITAL AND RESEARCH CENTER |