| CTRI Number |
CTRI/2024/03/064827 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Obesity Management in Ayurveda with Khadira saara churna tablets |
|
Scientific Title of Study
|
Effect of Khadira (Acacia catechu Linn.) saara churna in the management of Medodushti w.s.r to Overweight and Obese individuals - An open labelled clinical trial |
| 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 Santhosh N |
| Designation |
Post Graduate Scholar, Department of Dravyaguna |
| Affiliation |
KAHERS Shri BMK Ayurveda college |
| Address |
KAHERS Shri BMK Ayurveda college shahapur Belagavi Karnataka
Pin - 590003
Pin - 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
08618594508 |
| Fax |
|
| Email |
santhoshgowdabelli79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Chougale |
| Designation |
Proffesor and HOD Dept of Dravyaguna |
| Affiliation |
KAHERS Shri BMK Ayurveda college |
| Address |
KAHERS Shri BMK Ayurveda college shahapur Belagavi Karnataka
Pin - 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9964749993 |
| Fax |
|
| Email |
punarjeevam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Chougale |
| Designation |
Proffesor and HOD Dept of Dravyaguna |
| Affiliation |
KAHERS Shri BMK Ayurveda college |
| Address |
KAHERS Shri BMK Ayurveda college shahapur Belagavi Karnataka
Pin - 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9964749993 |
| Fax |
|
| Email |
punarjeevam@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Researches Ownes by Shri B M Kankanwadi Ayurvedic Mahavidyalaya and KLE Ayurveda Hospital Research Center Shahapur Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Santhosh N |
| Address |
KAHERS Shri B M Kankanwadi ayurveda mahavidyalaya, Shahapur |
| Type of Sponsor |
Other [Self sponsored pg dissertation work] |
|
|
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 Santhosh N |
KLE Ayurveda Hospital, Shahapur |
Vishuddha, OPD no 3, KLE Ayurveda Hospital, Shahapur, Belagavi, 590003, Karnataka
Belgaum
KARNATAKA |
8618594508
santhoshgowdabelli79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects |
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: Khadira Saara, Reference: Bhavaprakasha Nighantu Vataadi Varga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Male individuals of BMI above 25 to below 35
Male individuals aged between 18 to 50 years fulfilling diagnostic criterias |
|
| ExclusionCriteria |
| Details |
Patients having BMI below 25 and above 35
Female Individuals
Patients having age less than 18 years and more than 50 years
Patients having systemic disorders like, Hypertension, diabetes mellitus, Thyroidism etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight loss |
0th, 21st, 42nd |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in skin fold thickness in Middle portion of biceps and triceps muscle, Anterior surfeace of mid thigh region, Abdominal muscle at umbilicus, Subscapular region.
Anthropmetric changes in Neck, Abdomen, Mid arm, Waist, Mid thigh |
0th, 21st, 42nd |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/04/2024 |
| 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="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
|
Obesity is a serious and highly prevalant disease assosciated with increased morbidity and mortality. A thorough medical assessment is required to identify patients who are obese or at risk of obesity or obesity related complications. Considering Statistical data points, the number of obese individuals world is on ascent. As on 2022 information of WHO more than 1 billion individulas overall are obese, in that 650 million are grown ups, 340 million are teenagers and 39 million are youngsters. In India 135 million people were impacted by copulence. The commonness of obesity in India differs because of Age, Orientation, Tophographical climate, Financial status, and so on. WHO gauges that by 2025, around 167 million adults and kids will turn out to be less healthy as a result of obesity. In the classes of obesity, Overweight and Class one oobesity is more prevalant amongst population. In ayurveda classics Medodushti is pathological event which causes sthoulya and atisthoulya, which comes underAshtanindita. Both the words Medovriddhi(Sthoulya) and Medo dushti are used as synonyms of each other. Medo dushti is also root cause for hazardous complications viz, Hridroga and Prameha. The Khadira is explained by Acharya Sushruta under Saalasaaradi ghana and their saara as useful part. The properties of Saalasaraadi ghana are "Mehapanduaamayahara Kaphamedovishoshana". Bhavaprakasha explains the drug Khadira as "Tikta Kashaya Medhogna krumi meha jwara Vranaahareth" which means the drug efficiently reduces excessive meda. Building Certainity on sungle drug therapy and minimal expense with high compelling treatment is need of great importance. Keeping this in View single drug therapy with compelling dose w.s.r to Khadira (Acacia cathechu Linn) Saara is considered for the ongoing review. |