Study of Aarogyavardhini Vati and Navak Guggulu with Triphala Kwath in Obesity.

Phase 2/3

Recruiting

Conditions: Obesity, unspecified. Ayurveda Condition: MEDOROGAH,

Registration Number: CTRI/2023/01/048772

Lead Sponsor: Government Ayurved College and Hospital

Brief Summary: After Institutional Ethics Clearance of Government Ayurved College, Nagpur Screening of Population will be done from Patients in OPD, IPD, Casualty and Periphery of our institute. In the Clinical study 80 Patients of Sthaulya will include. Assessment of Symptoms will be done according to Scoring pattern by Gradation of Symptoms: Pattonder, R. K. et al (2011). During the informed consent process the subjects were given enough time to read patient information sheet and consent form. Subjects will also given freedom to ask the questions and all the questions would be answered.If he/she agrees for participation in the study and if found fit to include during screening then he will be recruited in the study.

If all inclusion criteria is YES and all exclusion NO then subjects will be included on the basis of criteria given. Subjects will then undergo general and systemic examinations.

**Parallel study design of Groups and Drugs Given in Respective Groups**

| | |

| --- | --- |

|**Group A**

**Group B**

|Assessment on zero-day

Assessment on zero-day

|Aarogyavardhini Vati 500mg 1BD with Lukewarm water

Triphala Kwath 50 ml BD for 15 days

With Sthaulyahar Aahar Vihar

Navak Guggulu 500mg 2TDS with Lukewarm water

Triphala Kwath 50 ml BD for 15 days With

With Sthaulyahar Aahar Vihar

|Administrated of drug by oral route

Administrated of drug by oral route

|Assessment on 16th day and after completion of treatment.

Assessment on 16th day and after completion of treatment.

|Collection of data and analysis

Collection of data and analysis

**Medium of Dissertation:** The study will be written in English and Sanskrit words will be used wherever necessary.

**Type of Study:** A Randomised control trial. Duration of Treatment: Total 45 days.

**Ethical Clearance:** Clearance from Institutional Ethics Committee of our institute.

**Study Centre:** OPD,IPD of Kayachikitsa and Casualty of our institute and periphery of Nagpur

**Duration of study:** study will be carried out for 18 months after approval of synopsis.

**Treatment Regimen:**

**Group A**

| | | | | |

| --- | --- | --- | --- | --- |

|Treatment given

Duration

Dose

Anupana

Bheshaja

Sevankala

|Aarogyavardhini Vati

30 days

500mg 1BD

Ushnodak

Before Morning Meal after Afternoon Meal

|Triphala Kwath

30days

50 ml

----

Before Morning and Afternoon Meal

**Group B**

| | | | | |

| --- | --- | --- | --- | --- |

|Treatment given

Duration

Dose

Anupana

Bheshaja Sevankala

|Navak Guggulu

30 days

500mg 2TDS

Ushnodak

Before and after morning And after Afternoon Mea

|Triphala Kwath

30days

50 ml

----

Before Morning and Afte

Meal

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 80

Inclusion Criteria

1.Patients having clinical features of Sthaulya (>50%) according to classics.
2.Patients of Sthaulya having BMI more than 25Kg/m2 and less than 40Kg/m2.
3.Patients of either sex of age between 18- 60 years are included.
4.Those patients of Sthaulya who are willing to participate in study and ready to give written consent will be included.
5.Patient who had not participated in any research work since last six months will be included.

Exclusion Criteria

1.Patients of Sthaulya having BMI less than 25Kg/m2 and more than 40Kg/m2 will be excluded.
2.Patients having age below 18yrs and above 60yrs will be excluded.
3.Patients of Obesity due to hypothyroidism and Obesity with having clinical history of any other systemic disorders like Ischemic heart disease Patients with complicated and chronic disorder like Nephrotic syndrome, Jaundice, Hepatitis, chronic infections and other serious diseases will be excluded.
4.Patients of Sthaulya with uncontrolled hypertension (systolic BP>140mmHg and diastolic BP >100mmHg) and uncontrolled diabetes (Fasting >130mg/dl and Post meal>200mg/dl) mellitus will be excluded.
5.Patients of drug induced Obesity for example Hormonal replacement therapy, consumption of anabolic steroids etc.
and any drugs that may influence on the outcome of the study will be excluded.
6.Pregnant females & lactating mothers will be excluded.
7.Patients who are currently participating in other clinical trials (since last six months) will be excluded.
8.Patient with evidence of malignancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Aarogyavardhini Vati and Triphala Kwath in Sthaulya w.s.r. to Obesity on symptoms of Sthaulya during period of 30 days.	30 days

Secondary Outcome Measures

Name	Time	Method
1.To compare the efficacy of Aarogyavardhini Vati and Triphala Kwath with Navak Guggulu and Triphala Kwath in Sthaulya wsrt Obesity.	2.To evaluate the efficacy of Aarogyavardhini Vati and Triphala Kwath in Sthaulya w.s.r. to Obesity on BMI and circumference of waist and hip.

Trial Locations

Locations (1): Government Ayurved College and Hospital
🇮🇳
Nagpur, MAHARASHTRA, India
Government Ayurved College and Hospital
🇮🇳Nagpur, MAHARASHTRA, India
Dr Mohini Jamale
Principal investigator
8856059854
mohinijamale@gmail.com