| CTRI Number |
CTRI/2025/02/080972 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic Management of Obesity
by Biopurificatory therapy, Diet and Yoga. |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of vamana karma followed by pathya -ahara and yoga in the management of sthaulya. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushboo k Marathe |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Panchakarma
Parul Institute of Ayurved
Parul University
PO Limda Tal Waghodia 391760
Dist Vadodara Gujarat
India
Vadodara GUJARAT 391760 India |
| Phone |
8788129778 |
| Fax |
|
| Email |
drkhushboomarathe@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nirmala Sonawane |
| Designation |
HOD and Professor of Panchakarma |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Panchakarma
Parul Institute of Ayurved
Parul University
PO Limda Tal Waghodia 391760
Dist Vadodara Gujarat
Vadodara GUJARAT 391760 India |
| Phone |
8329614671 |
| Fax |
|
| Email |
ayurved05@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nirmala Sonawane |
| Designation |
HOD and Professor of Panchakarma |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Panchakarma
Parul Institute of Ayurved
Parul University
PO Limda Tal Waghodia 391760
Dist Vadodara Gujarat
Vadodara GUJARAT 391760 India |
| Phone |
8329614671 |
| Fax |
|
| Email |
ayurved05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panchakarma OPD no- 105 and IPD,Parul Ayurved Hospital ,Parul University ,Limda ,Vadodara,Gujarat India ,pin no - 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Panchakarma - OPD no-105 and IPD
Parul Ayurved Hospital,parul university,Limda,Vadodara,
Gujarat India , pin no-391760 |
| 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 Khushboo k Marathe |
Parul Ayurved Hospital |
Department of Panchakarma
Parul Institute of Ayurved
Parul University
PO Limda Tal Waghodia 391760
Dist Vadodara Gujarat
India Vadodara GUJARAT |
8788129778
drkhushboomarathe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Human Research Parul Institute of Ayurved Parul University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDA-DHATUGATAJVARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् | (Procedure Reference: Charak samhita, Procedure details: poorva karma - Deepana,pachana,udvartana,snehapana
pradhana karma- vamanakarma
paschat karma - samsarjana krama
after samsarjana krama pathya ahara and yoga for 15 days) (1) Medicine Name: Murchita goghrita, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 5 Days(2) Medicine Name: varunadi kashaya, Reference: Astanga hridaya, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having sign and symptoms of sthaulya explained in Ayurveda Text
Age between 18years to 60 years irrespective of gender,caste,religion
Subjects having BMI Between 23.1-35kg per metre square
Subjects who are fit for vamana karma, shamana aushadhi and yoga
Subjects Who are ready to give written consents |
|
| ExclusionCriteria |
| Details |
Age less than 18years and more than 60years irrespective of caste, gender and religion
Sthaulya associated with other known diseases like cardiovascular disease, uncontrolled DM, uncontrolled hypothyroidism
Patients who are unable to carryout his or her own physical activities
Pregnant lady
Patients Who are unfit for vamana karma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the body weight from baseline |
60days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Reduction in the BMI
2 Changes in the lipid profile Reduction in total cholestrol ,LDL,Triglycerides HDL Levels
3 Reduction in the symptoms of Sthaulya |
30-35days |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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 3 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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 Yet Recruiting |
| 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
|
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Brief Summary
|
INTRODUCTION: Sthaulya is a Santarpanjanya Vyadhi described in Astonindatiya Adhyaya in Sutrasthana of Charaka Samhita. In Sthaulya, Medovaha Srota is affected due to which there is over production of Medodhatu. In modern medical science, Sthaulya is compared with obesity caused by excess calorie intake and also endocrinal disorders like Hypothyroidism, Cushing’s syndrome, also drug induced or due to genetic inheritance. Obesity is often defined as a condition of abnormal or excess fat accumulation in adipose tissue to the extent that the health becomes impaired. In santarpanjanit vyadhi sodhana procedures are beneficial. Vamana is one such karma which removes vitiated kapha and medo dosha which are prime dosas involved in Sthaulya. Along with vamana, dietary management and exercise play important role in the management of Sthaulya. Hence, the study aims in integration of various approaches described in Ayurveda NEED OF STUDY: A current world health study claims that obesity is included among the fifth selected risk to health. The prevalence rate of obesity in India is 40.3%, in south the ratio is highest and in east is lowest at 32.96% and prevalence ratio is seen more in females as compared to males ratio mentioned is 41.88% versus 38.67%. prevalence rate is high in female as compared to males. Management of Obesity in contemporary science includes various medications like appetite-supressing drugs and bariatric surgeries. They may lead to various side effects like depression, tachycardia, insomnia, bloating etc. There are also chances of bowel obstruction, gallstones, ulcers due to various bariatric surgeries .etc. There is a need of holistic management which would help in a sustainable effect without any undesirable side effects. This study is designed in such a way that most of the causes of obesity can be addressed and the treatment should be cost effective and also feasible for the patient. In this study we are combining vamana, dietary specifications and yoga, this will help the patient to achieve a long-term benefit with sustainable results. AIM: To evaluate the efficacy of vamana karma followed by pathya ahara and yoga in the management of Sthaulya OBJECTIVES • To study the combined effect of vamana karma, pathya ahara and yoga in the management of Sthaulya. • To study the changes in biochemical parameters by vamana karma, pathya ahara and yoga in the management of Sthaulya. HYPOTHESIS Null Hypothesis (H0):Vamana karma followed by pathya –ahara and yoga is not effective in the management of Sthaulya Alternate Hypothesis(H1): Vamana karma followed by pathya –ahara and yoga is effective in the management of Sthaulya RESEARCH QUESTION : Whether vamana karma followed by pathya-ahara and yoga is effective in the management of Sthaulya ? METHODOLOGY Study Design: An open labelled single arm clinical trial Sample size: 20 Duration of treatment: 30 -35days Selection criteria: 20 Patient will be selected from OPD and IPD of Parul Ayurveda Hospital Diagnostic criteria: classical clinical features of Sthaulya as Chala sphika udar stana, Alasya, Dourbalya, Kshudraswasa, Swedaadhikya Inclusion criteria: 1.Subjects having sign and symptoms of Sthaulya explained in Ayurveda text 2.Age between 18 years to 60 years irrespective of gender, caste, religion 3.Subjects having BMI between 23.1 to 35kg/m2 4.Subjects who are fit for vamana karma, shaman ausadhi and yoga. 5.Subjects who are ready to give written consents. Exclusion criteria: 1.Age less than18years and more than60years 2.Sthaulya associated with other known disease like hypertension, cardiovascular disease, uncontrolled hypothyroidism, uncontrolled diabetes mellitus 3.Patients who are unable to carry out his/her own physical activities 4.Pregnant lady 5.Patient unfit for vamana karma Assessment criteria : 1.Subjective criteria- Chala sphika udar stana, Alasya, Dourbalya, Kshudraswasa, Swedaadhikya 2.Objective criteria-BMI, weight, body circumference(chest, waist, pelvis, mid-arm, pelvis, mid-thigh) and lipid profile 3.Criteria for assesessment of vamana:- a. Number of vamana vega b.Duration of Vamana Vamana vyapat (complicatios if occur will be noted and treated immediately). c. Vitals of patient during Vegas Immediate discomfort to the patient . d.Achievement of Pittantika Shuddhi (Samyaka Vamana Lakshana ) e. Maniki Shuddhi f.Type of Shuddhi g vamana vyapat (complications if occur will be noted and treated immediately) Study duration – 18 months Follow up: on 0th day, after vamana, after completion of treatment, on 60th day Shodhana 1.Deepana and Pachana for 3-5 days- Chitrakadi Vati 2 BD A/F and Amapachak Vati 2BD B/F Along with Udvartana Witth Yava Churna + Triphala Churna 2.Snehapana for 3-7 Days with Murchita Goghrita 3.Vamana Karma with Vamana yoga –Madanphala pippali (6gram), yastimadhu churna (3gm), vacha(3gm), madhu(q.s.) 4.Samsarjana Krama for 3/5/7 days. Shamana and yoga 1.Breakfast – Boiled Moong / Channa /Lajja(Jowar/Bajra). 2. Lunch – Jowar Roti /Seasonal Vegetables/daliya 3. Dinner – Jowar Roti /Seasonal Vegetables /daliya. 4.Shamana Aushadhi – Varunadi Kashaya 20ml Bd B/F. Yoga and vyayama 1.Sukshma Kriya for10 mins 2.Suryanamaskar 2 times every morning and increased by 2 per weekly(acc. to strength of patient) |