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Comparative pharmacological and clinical study of Shatahva oral and local application on wrinkle. (One group without oral and another group having both oral and local application)

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 - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075650
Enrollment
100
Registered
2024-10-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Dr DY Patil deemed to be University School of Ayurveda Nerul Navi Mumbai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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) 2. Subjects who are showing signs of early aging such ass fine lines and wrinkles 3. Subject with Fitzpatrick skin types II to IV for Indian population. 4. 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) 5. 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. 6. Patients who are willing and sign the informed consent form and comply with study requirements. 7. Subjects who have not participated in similar investigation in the past four weeks. 8. 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.

Exclusion criteria

Exclusion criteria: 1. Patient suffering from acute, Chronic and progressive disease liable to interfere with the study data like DM, HTN, Hepatitis, or any serious medical illness. 2. 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). 3. Received any facial aesthetic treatments or oral retinoid within the last 6 months or anticipated during the study period. 4. 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) 5. Subjects having personal history of cosmetic, drug or domestic products with irritative reaction. 6. Immuno-compromised patients. 7. Pregnancy and lactating mother. 8. Food allergy or food intolerance. 9. Under any treatment known to interfere. 10. Not willing to discontinue other topical facial products. 11. On medications steroids, antioxidant. 12. Any serious medical and psychological condition will be excluded.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 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.

Secondary

MeasureTime frame
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.Timepoint: 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.

Countries

India

Contacts

Public ContactDr Shraddha Nayak

Dr. D.Y Patil deemed to be University. School of Ayurveda.

shraddha.nayak@dypatil.edu9619016727

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026