What is the treatment effect of three different dose regimes of Link Natural Swastha Amurtha (LNSA) against placebo in reducing facial acne and improving quality of life in participants who have mild to moderate facial acne?

Study setting: MAS Linea Aqua, a garment factory with over 3000 employees. Details about the study will be communicated by using the leaflet prepared in Sinhala, Tamil and English. Volunteer participants who fulfill the inclusion criteria will be recruited to the study.

Randomozation: Simple randomization method using computer-generated random numbers

Blinding: Neither participants, nor investigators, nor data collectors nor the study team nor data analysts will be aware of treatment assignments prior to the final breaking of codes of data base locks at the conclusion of the study

Intervention: Three doses of treatment and placebo granules will be packed into identical triple laminated sachets numbered from 1 to 88 by a senior R&D Scientist (Pharmacist) at Link Natural Products (Pvt) Ltd according to the list of computer-generated random numbers. Senior R&D Scientist (Pharmacist) will be involved in only in packaging the product according to random numbers given. After packing each sachet according to this list with three doses of treatment or placebo granules, the list will be placed in a sealed enveloped until completion of the trial. The groups of sachets will be handed over to the research team. Placebo granules contain inactive excipients and will be manufactured to have a similar appearance, taste, colour, smell and texture. Both directly observed therapy (DOT) and self-administration is used to administer treatment or the placebo. DOT is only possible during factory working days and during factory holidays and when participants are on leave sufficient sachets will be provided for self-administration. Recommended dose and directions for use including when / how / frequency will be given verbally when dispensing the sachets, and written instructions will be clearly mentioned on the label of the sachet in Sinhala, Tamil and English.

Dosage form of LNSA and placebo is granules, and it is dissolved in hot water/chilled water (as per individual preference) and will be administered orally.

LNSA which is the investigational product is prepared using traditional decoction of dried Nelli fruit (Phyllanthus emblica) and fresh Rasakinda stem (Tinospora cordifolia). It is manufactured by the Link Natural Products (Pvt) Ltd. As this is dose ranging study three doses of LNSA and placebo control is used as below. Low dose arm: 300 mg of total solid of Nelli Rasakinda decoction for 3 months period. Middle dose arm: 400 mg of total solid of Nelli Rasakinda decoction for 3 months period. High dose arm: 500 mg of total solid of Nelli Rasakinda decoction for 3 months period. Placebo arm: Placebo product for 3 months period.

All four arms will be given once daily oral dose dissolved in hot or cold water according to their preference.

1. Males and non-pregnant, non-nursing females, above 25 years, with mild to moderate facial acne.
2. Presenting minimum 5 acne lesions (whiteheads, blackheads, papules, pustules).
3. Investigator Global Assessment Scale for acne severity (IGA) at baseline should be below or equal 3
4. Participants who are not on any medical treatment for acne.

1. Use of any topical and systemic acne medical treatments or any antibiotics, if any, were not discontinued at least 4 weeks before entry into the study.
2. Participants who have received topical or oral isotretinoin or retinoid treatment in the 6 months prior to study inclusion.
3. Known allergy to ingredients of the product.
4. Use of hormonal therapy including oral contraceptive pills within 3 months prior to study commencement.
5. Any significant medical conditions that could confound the interpretation of the study.
6. Use of androgen receptor blockers (such as spironolactone or flutamide) in the 7 days prior to commencement of the study.
7. Have open infected acne lesions.
8. On any long-term medicines, including nutritional, Ayurveda/ herbal supplements.
9. Participants who have a history of Asthma or catarrh, diabetes or any other chronic or acute illness.
10. Those who are diagnosed with or showing major symptoms of a systemic disease-causing acne, such as polycystic ovarian syndrome, Cushing’s syndrome will excluded from the study.
11. Other facial skin or generalized dermatological disorders: rosacea, atopic dermatitis, perioral dermatitis, psoriasis etc..
12. Female subjects who are pregnant (positive urine pregnancy test) or lactating or who are planning to become pregnant during the study.