A Randomized Clinical Study On Krimighanadi Kashaya In Sthoulya With Special Reference To Obesity
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Improvement in Subjective and objective Parameters of Sthoulya
Study Overview
Brief Summary
This clinical study aims to evaluate the efficacy of Krimighanadi Kashaya in the management of Sthoulya (Obesity), a condition described in Ayurveda as Medo-dhatu vriddhi associated with Kapha-Vata imbalance and classified under Ashtau Nindita. With the global rise of obesity and its related metabolic complications, there is a growing need for safe, sustainable, and holistic treatment approaches. Ayurveda offers a comprehensive management strategy through Nidana-parivarjana, Ahara-Vihara regulation, and Medohara therapies. Krimighanadi Kashaya, a classical formulation containing Vidanga, Triphala, Ajmoda, Katuki, Trikatu, Guggulu, and Amrita, is traditionally indicated for Kapha-Medo disorders due to its Deepana-Pachana, Lekhana, Agnivardhaka and Medohara actions. This single-arm, open-label, randomized pre-post clinical trial will include 30 participants aged 18–60 years with BMI 25–39.9 kg/m². The intervention will be administered for 30 days with follow-ups on days 15, 30, and 45, assessing both Ayurvedic and biomedical parameters such as subjective symptoms of Sthoulya and BMI. The study intends to generate evidence on the therapeutic potential, safety, and overall effectiveness of Krimighanadi Kashaya in improving obesity-related clinical outcomes and restoring metabolic balance.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients of either sex of age between 18years to 60 years.
- •2.Patients having signs and symptoms of Obesity like large body frame having extra fat around the waist, difficulty in doing daily activities, lethargy, breathlessness increased weight, snoring, having sweating difficulty while sleeping.
- •3.Patients having classical signs and symptoms of Sthoulya like Chal Udara Stana Sphika, Javoparodha, Kruchvyavaya, Dourbalyta , Atikshudha, Atitrishna etc.
- •4.Patients with BMI between 25kg/m2 to 39 kg/m2 5.Patients willing to participate and able to provide signed informed consent.
Exclusion Criteria
- •1.Patients age less than 18 and more than 60 years.
- •2.Pathophysiology or Genetic Syndromes associated with Sthoulya.
- •3.Malignancy, poorly controlled diabetes mellitus, hypertension.
- •4.Patients suffering from pulmonary diseases, cardiac diseases will not be taken from study.
- •5.Alcoholic and drug abusers, pregnant and lactating women.
Outcomes
Primary Outcomes
Improvement in Subjective and objective Parameters of Sthoulya
Time Frame: Assessment: Percentage relief in symptoms and signs after 30 days of treatment.
Subjective:. Dourgandya
Time Frame: Assessment: Percentage relief in symptoms and signs after 30 days of treatment.
Ang Gourava,Utsaha Hani,Kshudra Swasa,Ati Pipasa, Chala Spikha Udara Stana,Dourbalya,Nidraadhikya,Swedadhikya Snigdhangata,Alpa Vyavaya
Time Frame: Assessment: Percentage relief in symptoms and signs after 30 days of treatment.
Objective:Body Mass Index
Time Frame: Assessment: Percentage relief in symptoms and signs after 30 days of treatment.
Secondary Outcomes
- 1.Change in Quality-of-Life Indicators(2.Improvement in Functional Capacity)
Investigators
Dr Apurva Gupta
Jammu Institute Of Ayurveda And Research