Randomized Open Labelled Prospective Comparative Pharmaco-Clinical Study to assess the efficacy of Shatahva (Anethum graveolens L.) Topically in the reduction of Vali –wrinkle with and without oral dosage form
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- a)Improvement in the fine lines parameters such as Forehead lines at rest, Upper eyelid laxity, Infra orbital laxity, Visible malar prominence, Fullness of buccal fat pad, etc.
研究概览
简要总结
TITLE OF STUDY
“RANDOMIZED OPEN LABELLED PROSPECTIVE COMPARATIVE PHARMACO-CLINICAL STUDY TO ASSESS THE EFFICACY OF SHATAHVA (ANETHUM GRAVEOLENS L.) TOPICALLY IN THE REDUCTION OF VALI –WRINKLE WITH AND WITHOUT ORAL DOSAGE FORMâ€
Background and Trial purpose of study:
Wrinkle, a major symptom of skin aging is a slow process that is linked to the loss of several basic skin characteristics like loss of skin elasticity and hydration. An inclusive approach targeting homeostasis internally as well as externally is needed in imparting anti-aging attributes. The Synthetic antioxidants damage the liver and other organs due to their toxic effects.
Therefore, the preparation of new effective natural antioxidant to rejuvenate the skin is very important and it is imperative to find a ubiquitous and inexpensive natural extract that can be used as an active ingredient.
In this study, Shatahva (Anethum graveolens L.) oral and Topical application is used. The phyto-pharmacological works on Shatahva (Anethum graveolens L.) have been widely explored and is known to have Antioxidant, Anti-inflammatory, and nutrient-rich properties suggesting its potential in promoting skin health and supporting collagen metabolism.
AIM & OBJECTIVES
AIM:
· To compare the efficacy of Shatahva (Anethum graveolens L.) Topically in the management of Vali –Wrinkle with and without oral dosage form.
PRIMARY OBJECTIVES:
· To determine the comparative impact between oral and topical application with topical application of Shatahva (Anethum graveolens L.) in the reduction of signs of ageing and tracking the improvement with reference to Vali (wrinkle) in comparison to baseline.
SECONDARY OBJECTIVES:
· To conduct Pharmacognostical analysis of the dosage form of Shatahva and to understand probable pharmacological action in Ayurveda and conventional medicine.
· To assess the safety and acceptance of the test product, in comparison to baseline.
· To critically review relevant literature on Shatahva, Vali, wrinkle from available Ayurveda classical texts as well as modern texts.
RESEARCH QUESTION AND HYPOTHESIS
RESEARCH QUESTION:
· Is there any significant difference between the efficacy of oral and topical application over topical application of Shatahva (Anethum graveolens L.) in improving outcome of Vali (wrinkle)?
HYPOTHESIS:
NULL HYPOTHESIS (H0):
· There is no significant difference in the efficacy of Shatahva used Combined oral and topical with topical application in the management of vali (wrinkle).
ALTERNATIVE HYPOTHESIS (H1):
· There is a significant difference in the efficacy of Shatahva used Combined oral and topical with topical application in the management of vali (wrinkle).
METHODOLOGY
Source of Patients – Healthy Volunteers willing to give consent will be enrolled for the study. Population for the study will be identified from those attending OPD & IPD of D.Y. Patil College, School of Ayurveda & Hospital and those willing for informed consent will be enrolled in the study.
ETHICAL CLEARANCE: Ethical clearance will be taken from ethical committee of D. Y. Patil Ayurvedic Hospital. Nerul.
TYPE OF STUDY: Interventional Clinical study
STUDY DESIGN: Double Arm Open prospective Randomized clinical Study.
SAMPLE SIZE – 100
WRITTEN AND INFORMED CONSENT: Before taking part in the study, volunteers will be asked for written agreement in a language they can understand, and volunteers will be informed about the investigation.
FOLLOW UP: Clinical Assessment will be done with baseline investigation and monthly primary outcome will be observed for 3 months.
COLLECTION OF MATERIAL: The entire Shatahva plant will be cultivated and Procured from Natural Habitat in accordance with Good Agriculture and collection Practices and verified during the fruiting season in Shishira Ritu, which occurs in the fall, the transitional season between summer and winter. The drug will be authenticated and Standardized from Authentic Laboratory before trial.
SOP for PREPARATION OF DOSAGE FORM
| DRAVYA |
LATIN NAME
FAMILY
RASA
GUNA
VIRYA
VIPAKA
PART USED
|Shatahva24
Anethum graveolens L.
Apiaceae
Madhura, Katu, tikta
Laghu, ruksha, tikshna
Sheeta
Madhura
Fruit
|Goghrita25
Madhura
Laghu, Snigdha, mrudu
Sheeta
Madhura
DOSE OF DRUG:
DOSE: 3-6 gm (Modified into convenient dosage form)
ANUPANA: Ghrita
BHESHAJA KALA: Internal- Annanakala (Rasayana kala)
Topical- Sayam (Evening)
DURATION -12 weeks
MODE OF ADMINISTRATION: Oral along with Topical Cream Application.
Sampling Technique-As the study is carried out in Healthy volunteers, empirically 100 subjects will be considered.
| Experimental Drug |
Experimental Drug
|Medicine
Shatahva
Shatahva
|Sample size
50
50
|Route of Drug Administration
Oral along with Topical Application
Topical Application
|Duration
12 weeks (Approx. 90days)
12 weeks (Approx. 90days)
|Assessments
Initial day 0th day, 30th day, 60th day, 90th day.
Initial day 0th day, 30th day, 60th day, 90th day.
ASSESSMENT CRITERIA
· Subjective assessment for the application site reaction:
Signs & Symptoms:
1. Skin firmness, Skin texture, visible pores, Evenness of skin tone and skin hydration
2. Overall wrinkles over face
3. Crow’s feet grading scale in unanimated face
4. Naso-labial folds
5. Frown lines
6. Homogeneity of age spots
7. Pores
8. Skin clarity
9. Skin smoothness
- Evenness of skin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 45.00 Year(s)（—）
入选标准
- •Subjects between the age group of 30-45 years & of any Gender.
- •(As per Acharya Sharangdhar, Complexion is seen in the 3rd Decade i.e. after 30years of age)
- •Subjects who are showing signs of early aging such ass fine lines and wrinkles
- •Subject with Fitzpatrick skin types II to IV for Indian population.
- •Subjects with signs of ageing such as fine lines, wrinkles, spots, pigmentations, uneven skin tone, etc., subjects with mild to moderate hyperpigmentation spots (ephilides, lentigines, PIH)
- •Volunteers who are ready to avoid taking food supplements or cosmetic products for face care and do not modify their regular diet, concerning fruit or vegetable intake and are indoor during Day-time.
- •Patients who are willing and sign the informed consent form and comply with study requirements.
- •Subjects who have not participated in similar investigation in the past four weeks.
- •The study included healthy subjects with skin photo-types from I to IV who were willing to not expose their skin to both natural and artificial UV.
排除标准
- •Patient suffering from acute, Chronic and progressive disease liable to interfere with the study data like DM, HTN, Hepatitis, or any serious medical illness.
- •Cutaneous marks on the experimental areas, which could interfere with the assessment of skin reactions (pigmentation disorders, scars, thick or excess hair, freckles and nevi in great quantity, sunburn or inflammatory conditions of the facial skin, including atopic dermatitis, psoriasis, and rosacea).
- •Received any facial aesthetic treatments or oral retinoid within the last 6 months or anticipated during the study period.
- •Active skin diseases (e.g. moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, active atopic dermatitis, melasma, lichen planus pigmentosus/ Ashy dermatosis, pigmented contact dermatitis or other cutaneous manifestations), with severe to chronic hyperpigmentation spots (ephilides, lentigines, PIH)
- •Subjects having personal history of cosmetic, drug or domestic products with irritative reaction.
- •Immuno-compromised patients.
- •Pregnancy and lactating mother.
- •Food allergy or food intolerance.
- •Under any treatment known to interfere.
- •Not willing to discontinue other topical facial products.
- •On medications steroids, antioxidant.
- •Any serious medical and psychological condition will be excluded.
结局指标
主要结局
a)Improvement in the fine lines parameters such as Forehead lines at rest, Upper eyelid laxity, Infra orbital laxity, Visible malar prominence, Fullness of buccal fat pad, etc.
时间窗: a)Improvement in the fine lines parameters such as Forehead lines at rest, Upper eyelid laxity, Infra orbital laxity, Visible malar prominence, Fullness of buccal fat pad, etc. | b) Improvement in the skin Characteristics and Physiological factors. | c) Improvement in the depth of the wrinkle after local application of the drug along with and without oral dosage form will be assessed at baseline, 4th week, 8th week, 12th week.
b) Improvement in the skin Characteristics and Physiological factors.
时间窗: a)Improvement in the fine lines parameters such as Forehead lines at rest, Upper eyelid laxity, Infra orbital laxity, Visible malar prominence, Fullness of buccal fat pad, etc. | b) Improvement in the skin Characteristics and Physiological factors. | c) Improvement in the depth of the wrinkle after local application of the drug along with and without oral dosage form will be assessed at baseline, 4th week, 8th week, 12th week.
c) Improvement in the depth of the wrinkle after local application of the drug along with and without oral dosage form will be assessed at baseline, 4th week, 8th week, 12th week.
时间窗: a)Improvement in the fine lines parameters such as Forehead lines at rest, Upper eyelid laxity, Infra orbital laxity, Visible malar prominence, Fullness of buccal fat pad, etc. | b) Improvement in the skin Characteristics and Physiological factors. | c) Improvement in the depth of the wrinkle after local application of the drug along with and without oral dosage form will be assessed at baseline, 4th week, 8th week, 12th week.
次要结局
- 1)Improvement in skin firmness, skin texture & visible pores, in comparison & assessed at baseline, 4th week, 8th week, 12th week.(2)The Product efficacy of the drug, Product Usability, safety Evaluation will also be done & assessed at baseline, 4th week, 8th week, 12th week.)
研究者
Dr Shivangi Mishra
Dr. D.Y Patil deemed to be University. School of Ayurveda.