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CTRI Number  CTRI/2025/09/094634 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 11/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Yashtimadhu extract capsule in weight loss management among lean individuals 
Scientific Title of Study   Effect of Yashtimadhu (Glycyrrhiza glabra) extract capsule in the management of Karshya with special reference to Under weight-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 Pooja Gorobal 
Designation  Post Graduate scholar 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003 
Address  Department of Drvyaguna, No 4 KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003

Belgaum
KARNATAKA
590003
India 
Phone  8971874149  
Fax    
Email  poojaggorobal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun Chougale  
Designation  Professor and HOD Dept of Dravyaguna 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003 
Address  Department of Dravyguna,No 4 KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003

Belgaum
KARNATAKA
590003
India 
Phone  9964749993  
Fax    
Email  punarjeevam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arun Chougale  
Designation  Professor and HOD Dept of Dravyaguna 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003 
Address  Department of Dravyaguna.No 4 KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003


KARNATAKA
590003
India 
Phone  9964749993  
Fax    
Email  punarjeevam@gmail.com  
 
Source of Monetary or Material Support  
KLE Academy of Higher Education Researchers Ownes by Shri B M Kanknawadi Ayurvedic Mahavidyalaya and KLE Ayurveda Hospital Research Centre Shahapur Belagavi-590003,India 
 
Primary Sponsor  
Name  Dr Pooja Gorobal  
Address  KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003 
Type of Sponsor  Other [Self sponsored PG Dissertation work] 
 
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 Pooja Gorobal  KLE Ayurveda Hospital and MRC Shahapur  OPD NO 3 KLE Ayurveda Hospital and MRC Shahapur Belagavi 590003
Belgaum
KARNATAKA 
08971874149

poojaggorobal@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E46||Unspecified protein-calorie malnutrition. Ayurveda Condition: KARSYAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Yashtimadhu Extract capsule , Reference: Bhavaprakash Nighantu,Haritakyadi varga shloka 143-145, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either gender of the age group between 18-60 years will be selected.
Patients with BMI less than 18.5kg/m2.
 
 
ExclusionCriteria 
Details  Patients of age group below 18 and above 60 years will be excluded.
Patients with Tuberculosis, Malignancies, Metabolic disorders & Hyperthyroidism.
Patients with other Chronic Systemic diseases.
Pregnant women and Lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in weight  0th,15th,30th and 45th day  
 
Secondary Outcome  
Outcome  TimePoints 
Anthropometric measurement & Body Mass Index (BMI).  0th,15th,30th and 45th 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 1 
Date of First Enrollment (India)   01/01/2026 
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  
Under nutrition is a widely acknowledged health issue in the developing countries of the world Under nutrition is a condition in which there is insufficient consumption, poor absorption or excessive loss of nutrients. Under nutrition can cause a range of health issues including weight loss, low energy, muscle wasting, anemia, infections and frequent illness. Under nutrition includes wasting (low weight for height), stunting (low height for age) and underweight (low weight for age). 
       According to both Asian and WHO standards, a Body Mass Index(BMI) of less than 18.5kg/m2 is classified as Underweight. The overall prevalence of underweight was 22.9% as per WHO, with approximately 10% of adults falling into this category. Among them, 6.2% of men and 7.0% of women are considered underweight.
 Under nutrition can be correlated with Karshya in Ayurveda. In Karshya, mainly Vata dosha is vitiated along with Rasa Dhatu Dushti and Agni Vaishamya. 
       According to Acharya Charaka, individuals who are excessively lean (Atikrushya) are classified under Ashtaninditiya  Purusha  and Karshya is an Apatarpanjanyavyadhi. 
Acharya Charaka has explained Brimhana as the primary line of treatment for karshya. Brimhana karma implies the action on Mamsa Dhatus promoting muscle tone and imparts a strong build. The drug possessing guru,snigdha, sheeta,sthira guna can cause Brimhana. These properties are primarily associated with Pruthvi Jala Mahabhuta.
Yashtimadhu (Glycyrrhiza glabra Linn) possesses Madhura rasa, along with Guru and Snigdha guna. Its virya is sheeta and vipaka is Madhura.
The active constituents of Yashtimadhu is glycyrrhizin , Glycyrrhetinic acid, Isoflavonoids, chalcones, triterpenoids, sterols, amino acids, amines, gums and volatile oils .The chemical constituents such as alkaloids, flavonoids, tannis and steroids(phytosterols) are present.
        In aligning with the Ayurvedic concept of Eka Mulika Prayoga – which emphasizes the use of a single herb for therapeutic application, this study integrates traditional principles with modern scientific approaches. Specifically, it explores the utility of isolated plant extracts in standardized, cost effective formulations to enhance therapeutic outcomes. Considering this, a single-drug intervention using Yasthimadhu Extract Capsules in an optimized dosage has been selected for the current clinical study.
 
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