CTRI/2025/10/095827 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On:
29/09/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Non-randomized, Active Controlled Trial
Public Title of Study
A Comparative Clinical Intervention On Powder Massage Purgation Followed By Vrikshamla Extract And Powder Massage Purgation Followed By Guduchi Bhadraadi Decoction In Obesity
Scientific Title of Study
A Comparative Clinical Study On Udvartana Virechana Followed By Vrikshamla Swarasa And Udvartana Virechana Followed By Guduchi Bhadraadi Kashaya In Sthoulya Wsr To Obesity
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Parisara H S
Designation
Post graduate scholar
Affiliation
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
Address
Room no 2 ,Department of Kayachikitsa,Sri Kalabhairaveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 10 Pipeline road Vijaynagar Bangalore Room no 2 ,Department of Kayachikitsa,Sri Kalabhairaveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 10 pipeline road Vijaynagar Bangalore Bangalore KARNATAKA 560104 India
Phone
9945983373
Fax
Email
parisarahs@gmail.com
Details of Contact Person Scientific Query
Name
Abdul Khader
Designation
Professor
Affiliation
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
Address
Room no 2,Department of Kayachikitsa, Sri Kalabhairaveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 10 Pipeline road Vijaynagar Bangalore Room no 2 ,Department of Kayachikitsa,Sri Kalabhairaveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 10 Pipeline road Vijaynagar Bangalore Bangalore KARNATAKA 560104 India
Phone
9845199790
Fax
Email
abukaya2003@gmail.com
Details of Contact Person Public Query
Name
Abdul Khader
Designation
Professor
Affiliation
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
Address
Room no 2,Department of Kayachikitsa, Sri Kalabhairaveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 10 Pipeline road Vijaynagar Bangalore Room no 2 ,Department of Kayachikitsa,Sri Kalabhairaveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 10 Pipeline road Vijaynagar Bangalore Bangalore KARNATAKA 560104 India
Phone
9845199790
Fax
Email
abukaya2003@gmail.com
Source of Monetary or Material Support
Sri Kalabhairaveshwara Ayurvedic medical college Hospital and research centre
Primary Sponsor
Name
Parisara H S
Address
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 10 Pipeline road Vijaynagar Bangalore
Type of Sponsor
Other [self]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Kiran M Goud
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
room number 2,Department of Kayachikitsa Bangalore KARNATAKA
9845109556
kiranmgoud@yahoo.co.in
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
SKAMCH AND RC
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: MEDOVRUDDHIH,
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Intervention Arm
Procedure
-
virecana-karma, विरेचन-कर्म
(Procedure Reference: Charaka sutrasthana 21st chapter, Procedure details: Sarvanga udwartana with triphala & kolakulattadi churna for 7 days followed by snehapana with moorchita taila until samyak snigdha lakshanas is attained followed by vishrama kala for 3 days sarvanga abhyanga with moorchita taila followed by Virechana with trivrut avaleha with Anupana as ushna jala ) (1) Medicine Name: Triphala, Reference: Bhavaprakasha, Route: Topical, Dosage Form: Churna/ Powder, Dose: 500(g), Frequency: od, Duration: 7 Days(2) Medicine Name: kolakulattadi churna, Reference: Bhavaprakasha, Route: Topical, Dosage Form: Churna/ Powder, Dose: 500(g), Frequency: od, Duration: 7 Days(3) Medicine Name: Moorchita taila, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 4 Days(4) Medicine Name: Moorchita taila, Reference: Bhaishajya ratnavali, Route: Topical, Dosage Form: Taila, Dose: 250(ml), Frequency: od, Duration: 3 Days(5) Medicine Name: trivrut avaleha, Reference: Ashtanga hridaya kalpa sthana, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 50(g), Frequency: od, Duration: 1 Days(6) Medicine Name: Vrikshamla swarasa, Reference: Bhava prakasha, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 12(ml), Frequency: bd, Duration: 30 Days
2
Comparator Arm
Procedure
-
virecana-karma, विरेचन-कर्म
(Procedure Reference: Charaka sutrasthana 21st chapter, Procedure details: Sarvanga udwartana with triphala & kolakulattadi churna for 7 days followed by snehapana with moorchita taila until samyak snigdha lakshanas is attained followed by vishrama kala for 3 days sarvanga abhyanga with moorchita taila followed by Virechana with trivrut avaleha with Anupana as ushna jala ) (1) Medicine Name: Triphala, Reference: Bhava prakasha, Route: Topical, Dosage Form: Churna/ Powder, Dose: 500(g), Frequency: od, Duration: 7 Days(2) Medicine Name: kolakulattadi, Reference: Bhavaprakasha, Route: Topical, Dosage Form: Churna/ Powder, Dose: 500(g), Frequency: od, Duration: 7 Days(3) Medicine Name: moorchita taila, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 4 Days(4) Medicine Name: moorchita taila, Reference: bhaishajya ratnavali, Route: Topical, Dosage Form: Taila, Dose: 250(ml), Frequency: od, Duration: 3 Days(5) Medicine Name: trivrut avaleha, Reference: Ashtanga hridaya kalpa sthana, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 50(g), Frequency: od, Duration: 1 Days(6) Medicine Name: Guduchi bhadraadi kashaya, Reference: Charaka sutra sthana, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 24(ml), Frequency: bd, Duration: 30 Days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
subjects belonging to the age group 18 to 60 years
subjects fit for udvartana
subjects fit for Virechana karma
subjects of either gender presenting with clinical features of sthoulya
subjects of either gender presenting with clinical features of obesity
BMI from 25 to 39
ExclusionCriteria
Details
any systemic diseases that interfere with the course of treatment
pregnant and lactating women
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
Alternation
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
To see the amount of weight reduction by measuring the skin fold thickness girth circumference and BMI and other parameters in two treatment modalities viz Udvartana Virechana followed by oral administration of Vrikshamla swarasa and Guduchi Bhadraadi kashaya in the management of sthoulya wsr to Obesity
Before the commencement of intervention-1st day
On the day of completion of Udvartana-after one week
After completion of Virechana
After completion of intervention-after 8 weeks
Secondary Outcome
Outcome
TimePoints
nil
nil
Target Sample Size
Total Sample Size="40" Sample Size from India="40" 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
Date of First Enrollment (India)
10/10/2025
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="25"
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 disease of caloric imbalance that results from an excess intake of calories that exceeds their consumption of various food items by the body. Lifestyle diseases depends upon day-to-day habits and sedentary routine that causes many health problems.
About 16% of adults aged 18 years and older worldwide were obese in 2022.1According to WHO, a BMI greater than or equal to 25 is considered as overweight and a BMI greater than or equal to 30 as Obesity.2 Apart from this, hormonal imbalance also contributes to the accumulation of fat stores.3
Sthoulya is a Santarpanajanya Vyadhi.4Meda is increased in the body due to intake of shleshmala and medovruddhikara ahara and due to lack of physical exercises, divaswapna, achintha. Due to more kaphakara and medovruddhikara ahara vihara there is undigested food left in the stomach that leads to ati snigdhatha and lead to the formation of ama.The atimatra upachaya of medas due to medodhatwagnimandhya causes margavarana by medas.Vata will get confined to koshta which leads to ahara shoshana and sheegra ahara jarana.Athikanksha of ahara will ultimately lead to atisthoulya.4It is the abnormal and excessive accumulation of Medodhatu in the body and is one of the Medodoshaja Vikaras.5Acharya Charaka considered Atisthula as one among Ashtonindita Purusha.6A person having pendulous appearance of sphik, udara and sthana due to excess deposition of meda along with mamsa dhatu having unequal and abnormal distribution of meda with reduced enthusiasm towards life is called atisthula7 .
Acharya Charaka has mentioned Sleshma- medohara Ahara ,ruksha Udvartana along with Guru Ahara and Atarpana Chikitsa as the line of treatment for Sthoulya⬚8. Sneha purva rukshana is indicated in Mamsala, medhura, bhurisleshma, vishamagnyaha.9
Udvartana is having the Gunas of Kapha-MedaVilayana property. The Virya of the medicine enters the body due to Ushna and Tikshna Guna of Dravya and its powerful influence on Romakupa. It then opens the Mukha of Sira, resulting in Paka of Kapha and Medas. There will be Dravata Vriddhi of the Kapha and Medas as a result of this,Swedana, which comes after Udvartana, gives to the Paka of the same. As a result, Nirharana of Vikrita Kapha Dosha, Dushya along with Medo Dhatu (Alleviation of vitiated Kapha and Meda) and removes avarana and srotorodha will take place ultimately resulting in laghutva of Sharira.10
4
Virechana karma does the Sroto-avarodha and normalizes the Agni.11According to Charaka Samhitha, Sthoulya is a Bahudoshaja Vyadhi hence Shodhana is advocated.12Virechana karma is one of the treatment modalities for treating Santarpanajanya
Vikaras.13⬚ The principal action of Virechana Karma is elimination of vitiated Pitta Dosha which
is the important factor in the regulation of Agni. Drugs of Virechanaa Karma have maximum ingredient of Katu Rasa, Laghu, Ruksha Guna, Ushna Virya and Katu Vipaka, Vatakapha Shamaka, Karshana, Lekhaniya, Medorogahara, Amapachana, Dhatu-Shoshana properties, which normalize the state of Agni. After Virechana Karma, followed by Samsarjana Karma, it leads to Agnivridhi and Amahara. By Virechana Karma all Srotas especially Medovaha andRasavaha Srotas gets purified.14
Vrikshamla fruits has Amla, Katu and Madhura Rasa. It has Laghu and Ushna Guna. It has deepana, rochana and kapha-medohara properties.15,38 Due to its Laghu and Ushana Guna it digests the Amasanchaya and clears the Srotorodha.Vrikshamla has inherent tendency of agnisamdhukshana. Many studies have shown that intake of HCA present in Vrikshamla reduces appetite, inhibits lipogenesis and reduces body weight.16 The active components of Garcinia indica is hydroxycitricacid (HCA),garcinol,cyanidine-3-sambubioside,cyanidin-3- glucoside has anti-obesity effect.17
Guduchi contains guru, snigdha guna ,ushna virya, tikta kashaya rasa, medohara property and it is indicated in medoroga.18,19Triphala contains laghu, ruksha guna,it has tridoshahara, lekhana property.20,21Musta contains katu, tiktha, kashaya rasa, deepana, pachana, grahi, kapha pittahara properties.36Guduchi Bhadraadi kashaya is indicated insthoulya.37These drugs have potent antihyperlipidemic activity and does kaphamedohara activity with life style modification, daily practice of exercise is needed.
In this view of thinking the present study is taken to compare the effect of Udvartana,Virechana followed by oral administration of Vrikshamla rasa and Guduchi Bhadraadi kashaya in the management of Sthoulya w.s.r to obesity.