A Prospective, Open-label, single arm study to evaluate the safety and efficacy of oral consumption of Turmeric Ghee (Ghritham) in improving skin health.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Percentage Improvement in skin brightening and skin
研究概览
简要总结
Formulation Turmeric Ghee combines the time-tested therapeutic potential of Haridra Curcuma longa Linn with the nourishing and tissue-penetrating qualities of Go-Ghrita cows ghee. This combination is specifically indicated for skin-related disorders, age-associated degeneration, and Rasa Rakta Dushti vitiation of bodily fluids and blood. In Ayurveda, skin health is not just superficial but reflects the equilibrium of Doshas, nourishment of dhatus especially Rasa, Rakta, and Meda, and efficient detoxification. Disturbances in these lead to conditions such as Twak Sosha dryness, Vaivarnya discoloration, Mukha Dooshika acne, and Jara premature aging. Turmeric Ghee addresses these root imbalances through its multipronged therapeutic approach.
Our formulation Turmeric Ghee combines the time-tested therapeutic potential of Haridra Curcuma longa Linn with the nourishing and tissue-penetrating qualities of Go-Ghrita cows ghee. This combination is specifically indicated for skin-related disorders, age-associated degeneration, and Rasa Rakta Dushti vitiation of bodily fluids and blood. In Ayurveda, skin health is not just superficial but reflects the equilibrium of Doshas, nourishment of dhatus especially Rasa, Rakta, and Meda, and efficient detoxification. Disturbances in these lead to conditions such as Twak Sosha dryness, Vaivarnya discoloration, Mukha Dooshika acne, and Jara premature aging. Turmeric Ghee addresses these root imbalances through its multipronged therapeutic approach
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian male/female volunteer aged between 25-50 years (both inclusive) from different cities.
- •Subjects willing to give Informed Consent Form.
- •Subjects willing to complete the study assessments/questionnaires.
- •Fitzpatrick Skin Type I–V.
- •Minimal to moderate Allergen Skin Roughness Scale.
- •Subjects diagnosed with mild to moderate acne vulgaris based on the Global Acne Grading System (GAGS) score.
- •Stable vitals and no major systemic illness affecting metabolism or skin health.
- •Controlled Hypertension and RBS.
- •Willing to avoid usage of his/her own face serum and cream for at least one week before commencement and during this study.
排除标准
- •Subjects with preexisting severe systemic disease necessitating longterm medication
- •Subjects with mild to severe anaphylaxis reactions to turmeric, dairy or related substances
- •Evidence of significant uncontrolled comorbid disease like
- •Type 1 or Type 2 Diabetes Mellitus or uncontrolled blood sugar levels RBS greater than 140 mg/dL at baseline
- •History of dyslipidemia or metabolic syndrome
- •Diagnosed PCOS polycystic ovarian syndrome, thyroid disorders, or other hormonal imbalances
- •GAGS score greater than 30 severe acne with deep nodulocystic lesions or acne conglobata
- •Presence of active dermatitis, eczema, psoriasis, or rosacea
- •Hyperpigmentation disorders like melasma, vitiligo, etc
- •Pregnancy or breast feeding.
- •Participants using oral or topical turmeric supplementation within 4 to 6 weeks
- •Patients with recent skin treatment like use of systemic retinoids, use of topical retinoids, steroids, or antibiotics and undergoing chemical peels, laser therapy, or microneedling for acne within the past 6 months
- •Any neurological congenital or acquired, vascular or systemic disorder which could affect any of the efficacy assessments
- •Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.
结局指标
主要结局
1. Percentage Improvement in skin brightening and skin
时间窗: Day 0 day 30 and Day 60
hydration (Twak Prasannata) using instrument
时间窗: Day 0 day 30 and Day 60
corneometer and Allergan Skin Roughness Scale from
时间窗: Day 0 day 30 and Day 60
baseline (Visit 1, Day 0) to study completion (Visit 4,
时间窗: Day 0 day 30 and Day 60
Day 60).
时间窗: Day 0 day 30 and Day 60
2. Percentage reduction of Trans Epidermal water loss
时间窗: Day 0 day 30 and Day 60
using Tewameter instrument.
时间窗: Day 0 day 30 and Day 60
3. Percentage Reduction in Mukha Dushti Lakshana
时间窗: Day 0 day 30 and Day 60
(facial skin issues) using Global Acne Grading System
时间窗: Day 0 day 30 and Day 60
(GAGS) score from baseline to study completion.
时间窗: Day 0 day 30 and Day 60
4. Effectiveness in managing signs of aging
时间窗: Day 0 day 30 and Day 60
(Vayahsthapana) using Wrinkle Severity Rating Scale
时间窗: Day 0 day 30 and Day 60
(WSRS) from baseline to day 60.
时间窗: Day 0 day 30 and Day 60
次要结局
- 1. Percentage improvement in Immunity (Ojas) –(Evaluated using the Immune Status Questionnaire)
研究者
DrMadan Mohan N T
Sri Venkateshwara Hospital