| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E46||Unspecified protein-calorie malnutrition. Ayurveda Condition: KARSYAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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.
|
|
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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. |