| CTRI Number |
CTRI/2022/08/044689 [Registered on: 16/08/2022] Trial Registered Prospectively |
| Last Modified On: |
18/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of Mudgadi Peya as Pathya in sthoulya w.s.r. to obesity |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of Mudgadi peya as pathya in sthoulya w.s.r. 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 Suhel Ahmed A Gundur |
| Designation |
PG Scholar |
| Affiliation |
RGUHS University |
| Address |
Department of Pg Studies in Swasthavritta, 2nd
Year
Sri Sri College of Ayurvedic Science and Research, Bangalore
21 KM, Kanakapura Road, Bengaluru, Karnataka 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9880373781 |
| Fax |
|
| Email |
suhelgundur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikhila B Hiremath |
| Designation |
Professor |
| Affiliation |
RGUHS University |
| Address |
Sri Sri College of Ayurvedic Science and Research Bengaluru, Karnataka 560082
Sri Sri College of Ayurvedic Science and Research Bengaluru, Karnataka 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9538808990 |
| Fax |
|
| Email |
hiremath.nikhila6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suhel Ahmed A Gundur |
| Designation |
PG Scholar |
| Affiliation |
RGUHS University |
| Address |
Department of PG Studies in Swasthavritta, 2nd
Year
Sri Sri College of Ayurvedic Science and Research, Bangalore
21 KM, Kanakapura Rd, Bengaluru, Karnataka 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9880373781 |
| Fax |
|
| Email |
suhelgundur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research, Hospital |
|
|
Primary Sponsor
|
| Name |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Sri Sri College of Ayurvedic Science and Research
21st Km Kanakpura Road,Udayapura, Bangalore
560082
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Suhel Ahmed A Gundur |
Sri Sri College of Ayurvedic Science and Research, Hospital |
Room No. 07,
Swasthavritta
Department, Opd
and Ipd Section,
Banglore 560082
Bangalore
Karnataka
Bangalore
KARNATAKA |
9880373781
suhelgundur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kulathadi Yusha , Reference: Kaideva Nighantu , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 200(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mudgadi Peya , Reference: Chikitsa Manjari , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 200(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects with BMI 25-34.9 kg/m2
2)Age group between 21-45 years, irrespective of their gender, religion and socio-economic status
|
|
| ExclusionCriteria |
| Details |
1)Subjects with BMI 35 kg/m2 and above
2)Subjects with any systemic disorders
3)Pregnant and Lactating women
4)Subjects taking drugs like NSAID’s, Anti-histamines, oral contraceptives etc.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in BMI and Anthropometric measurement after 15 days of administration of the intervention |
Assessment will be done on:
Pre-Study Assessment- 0th Day
1st Assessment- 15th Day
1st Follow up- 20th Day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in classical sign and symptoms of
sthoulya-that is
Cala Sphik - Udara - Stana
Krichha Vyavayta (Loss of Libido)
Angagandha (Bad Odour)
Swedadhikya (Perspiration)
Kshudha-Adhikya (Increased Appetite)
Pipasa-Adhikya (Increased Thirst)
Kshudra Shwasa (Exertional Dyspnoea)
Nidradhikya (Increased Sleep) |
Assessment will be done on:
Pre-Study Assessment- 0th Day
1st Assessment- 15th Day
1st Follow up- 20th Day
|
|
|
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)
|
16/08/2022 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Obesity is
a type of nutritional disorder, due to imbalance between energy intake and energy
expenditure resulting in positive energy balance, characterized by the abnormal
growth of adipose tissue, resulting in an increase in the body weight. Recent
studies have reported that globally, more than 1.9 billion adults are
overweight and 650 million are obese. In India, more than 135 million
individuals are affected by obesity. Sthoulya is defined
as excessive and abnormal increase of medo dhatu along with maamsa
dhatu resulting in pendulous appearance and chalatwa of spik, udara and
sthana. Body mass
index (BMI) is a simple index of weight-for-height that is commonly used to
classify overweight and obesity in adults. An obese
person is always prone to develop the complications like, Coronary heart
disease, Diabetes mellitus, Osteoarthritis, Dyslipedemia, Hypertention as well
as psychological disorders like Anxiety, Stress and Depression. Practicing
appropriate Pathya is given equal importance, along with the treatment
in the management of Sthoulya.
Acharyas advised to consume guru-atarpana, kapha-vatahara ahara dravyas in management of sthoulya |