INTRODUCTION:

Acne vulgaris is along-lasting inflammatory skin condition that affects the pilosebaceous follicles and causes a variety of lesions on the face and neck, including comedones, papules, pustules, cysts, andnodules¹. The frequency of acne vulgaris is particularly high among young people and its prevalence is increasing, possibly due to factors like irregular sleep patterns, poor dietary choices, and excessive stress. Ayurveda attributes the development of acne to the vitiation of Kapha, Vata, and Rakta, resulting in the formation of thorn-like eruptions on the face². "Shalamali gel" is taken as a trial drug, as explained in the Ayurvedic classics. Here, I developed innovative drug formulation by using (SOP) standard operating procedures.

Crushing the thorns of Shalmali with milk and applying it to the face is effective in reducing Acne vulgaris (Youvanpidika)³. Shalmlikantak Lepa, which is natural, harmless and effective in treating acne, is transformed into a gel for convenience of application.⁴ Acne is classified into four grades based on the type and number of lesions present. Grade-I acne has fewer than 30 comedones, while Grade-II and III include comedones, pustules, and cysts. The most severe form, Grade-IV acne, is acne conglobata, characterized by large pustules, cysts, and scarring.⁵

Case Study:

A 26 years old female arrived with her face covered with comedones, inflamed pustules, nodules and scars. Patients’ history of acne since 3 to 4 years. Now days she has been working in morning job. Patient shows symptoms of Acne vulgaris Grade III Nodular acne along with local Rubor, inching, burning sensation, and etc. symptoms were suggested as a case of Acne Vulgarisgrade III.

· Past History: No other past history was noted according to patient statement.

· Aggravating Factors: There was frequently consumption of oily-spicy, non-veg diet, incompatible diet.

Ayurvedic classics and patient’s complaints:

1. Pidika (Acne on Face)

2. Vedana (Pain)

3. Kandu (Itching)

4. Daha (Burning Sensation)

5. Mamsal (Nodular)

6. Vaivarnya (Discolouration of Facial Skin)

7. Srava (Discharge)

8. OilyFace

Associated Symptoms:

a) Constipation (Malbadhdata)

b) Indigestion (Agnimandya)

Patient had above complaints since last two years.

Personal history:

Table No 1: personal history

1.Age: 26years	8.Sleep: inadequate
2.Sex: female	9.Addiction: none
3.Occupation: job	10.Bowelhabbit: irregular
4.Maritalstatus: married	11.Appetite: poor
5.Dehabala: madhyam	12. Bp:110/80 mmhg
6.Mansikbala: uttam	13Height: 5.4’’
7.Prakriti: pittavataj	14Weight: 52 kg

Table No 2: Ashtavidha Pariksha⁶

1.Nadi (pulse): 80/min	5.Shabda (Speech): Clear
2.Mala (stool): Constipation	6.Sparsh (Touch): Samshitoshna
3.Mutra (Urine): Normal	7.Druka (vision): Normal
4.Jivha (Tounge): Saam(coated)	8.Aakriti (Built): Madhyama

Samprapti⁷:

Table No 3: samprapti ghataka⁸

1.Dosha-Kapha, Vata Dushya	6. Shrotodusti - Sanga
2.Dhatu-Rasa, Rakta, Meda	7.Udbhavasthana-Ama-pakwashay
3.Upadhatu –Twacha	8.Sancharasthana–Sarvashareera
4.Agni - Jatharagnimandya	9.Vyaktasthana–Mukha
5.Srotas-Svedavaha, Raktavaha	10. Adhisthana– Twak

Nidana of Youvanpidika (Cause):

Table No 4: showing causes ofacne

Aahar(diet)

Viharaj

(Physical

activities)

Manas

(Psychological)

Kalaj

(Season)

Excessive intake of Katu(pungent), Amla(sour) and LavanRas(salty), Ushna(hot), Tikshna (Spicy), Abhishyandi (slimy), Snigdha (Eliphatic) and Guru Guna (heaviness), Oily food material, Chinese food, Dairy milk product, Glucose diet etc.

Divaswapna (Day Sleeping), Ratrijagaran (latnight sleeping), Atiaatapsevan (exposure to sunlight), Anidraor Alpnidra (insomnia).

Atikrodha

(anger), Atishoka (feeling depressed), Atichinta (Anxiety), Atibhaya (Fear), Swabhav

(Nature)

Sharad (Autumn), Grishma (Summer) and Vasant Ritu (Spring)

Treatment:

Gels are often preferred for treatments because they feel comfortable on the skin—non-greasy and not sticky. People are fond of them, particularly in areas where a greasy or sticky feeling is not desired. Additionally, gels are made to be absorbed quickly into the skin, which is beneficial for fast and effective treatment. The treatment approach involved the external application of Shalmali Gel.

Bark of Shalmali contains lupeol which possesses anti-inflammatory, anti-microbial and anti-oxidant properties which in turns subsides inflammation, combats acne causing bacteria and maintains skin integrity. Also prevents post acne scaring with its anti-oxidant properties.

Application - Gently Shalmali gel was applied all over face after rinsing face with plain water morning and evening.

Duration – for 45 days.

The gel was found to possess favorable physical and chemical properties, including a reddish brown color, a pleasant odor, a semisolid state, translucency, and an appropriate pH. The gel exhibited good spread ability and did not cause any irritation or adverse effects during irritancy testing.

Preparation of Shalmali Gel:

Table no 5: Shalmali GelIngredients

Sr. No	Drug Name and Part Used	Quantity
1	Shalmali Bark (Latin name-Bombax cebia) Family: Bombacaceae, Botanical: Bombaxcebia L	25g
2	Carbopol940	0.5 g
3	Phenoxyethanol	0.25g
4	Prpoylinglycol 400	2.5 g
5	EDTA	0.015g
6	Triethanolamine	0.6 g

The herbal drug was authenticated at Agharkar Research institute. According to API, different physical and chemical tests were performed on an herbal drug. The physico-chemical analysis was carried out as per API guideline.

Shalmali gel was made using the conventional gel preparation method:

To enhance the surface area for extraction, 25gm of dry bark were obtained and broken into little pieces.

Preparation of Shalmalibark decoction:

Shalmali bark powder, weighing 100g was placed in a stainless-steel container. The container was filled with 1600ml of water (sixteen times of Salmali bark). The mixture was then cooked over medium heat until 1/8^thpart (200ml)was remained.

Finally, the decoction was obtained by filtering the mixture through muslin cloth⁹

Preparation of shalmali gel:

A200-mLdecoction of Shalmali bark was prepared at room temperature. To this mixture, (2g) of 1%carbopol 940P, (10g) of 5% propylene glycol 400, (0.06g) of 0.03% EDTA, and (1g) of 0.5% phenoxyethanol were added. The mixture was then left undisturbed for 6-7 hours to allow the carbopol to disperse. Then, using an overhead mechanical stirrer, create a homogenous mixture at 1200rpm to form gel. The homogeneous liquid was Neutralised with the needed amount of Triethanolamine drop by drop with constant stirring until it was turned into a gel of the desired consistency and pH.¹⁰

Physico-analytical testing:

Table no 6: physico-analytical testing

Parameters	TestObservation
Description	Colour-RedishBrown Odors-Pleasant
State	Semisolid
Visual appearance	Translucent
Homogeneity	Consistent
pH	6.8
Viscosity	at20 rpm –367.2, at 60rpm-186.4
Spreadability	Easily Spreadable
Irritancy test	No Redness, No edema, Noinflammation and Irritation during Irritancy test

MATERIAL AND METHODS:

Homogeneity:

A small amount of gel was tested by pressing it between the index finger and thumb. To assess the texture and homogeneity of the gel, its consistency and the presence of coarse particles, if any, were taken into consideration¹¹.

pH determination:

pH determination of Gel was performed by using Digital pH meter previously calibrated with standard buffer solutions¹².

Viscosity:

Using a Brookfield viscometer at 20RPM and 100RPM DV II + Pro with a T-bar spindle with helipath adjustment, the viscosity of the gel was determined.The right T-bar spindle was chosen to produce torque readings between 10 and 100. At 25⁰C, the viscosity of the gel on the screen wasnoted¹³.

Spreadability:

With equipment's glass slides were cleaned with alcohol and dried. 1 gram of gel was placed between the two glass slides. The sample was then compressed to a uniform thickness with100g of weight placed on the top slide for 5 minutes. The pan's initial weight (100g) was added. The pan's weight was increased until the ascending slide above began to travel over the stationary slide. The time required to separate the two slides in seconds was recorded. Duplicate reading of each sample was taken and the time and distance traversed by slide was noted¹⁴.

Irritancy test:

On the left hand's dorsal surface, a one-square-centimeter area was marked. The sample gel was applied to this designated area, and the time of application was recorded.At regular intervals upto 24 hours, checks were conducted for any signs of irritancy, erythema, or edema, and the observations werere ported¹⁵

Assessment criteria of Yuvanapidika(Acnevulgaris):

Table no 7: Assessment criteria of acne vulgaris

Parameter	Assessment criteria
Sotha (Swelling)	0-Less, 1-Moderate,2Severe
Sula (Pain)	0-No pain, 1-Mild pain, 2-severepain
Srava (Discharge).	0-No Srava, 1-Lasika,2-Puya
Kandu (Itching)	0-No Kandu, 1-Mild,2-Moderate, 4-Severe
Vivarnata (Discoloration of Facial Skin)	0-No Vivarnata, 1-Mild, 2–Moderate, 3-Severe
Daha (Burning Sensation),	0-No Daha, 1-Mild, 2-Moderate, 3-Severe
Area involved	Cheeks and chin, Wholeface and trunk

RESULT:

After 15 days of treatment, the patient reported relief from Kandu (itching) and Daha (burning sensation), whereas improvement was seen in Sula (pain) and Sarva (discharge). After 30 days of treatment, Sula(pain) disappeared completely, whereas Sotha (swelling) and Vivarnata(discoloration of facial skin)reduced considerably. After 45 days of treatment, improvement was seen in most of the symptoms. Assessments on each symptom of youvanpidika (Acne vulgaris) have been presented in Table 8. Figure 1 depicts the manifestation of acne on the skin prior to any treatment. In contrast, Figure 2 illustrates the aftermath of applying a gel treatment, showcasing a significant improvement in skin condition.

Table no 8: Results of assessment criteria

Sr. No	Symptoms	Before Treatment	AfterTreatment
Sr. No	Symptoms	Before Treatment	15 days	30 days	45 days
1	Sotha (Swelling)	2	2	1	0
2	Sula (Pain)	2	1	0	0
3	Srava (Discharge)	2	1	1	0
4	Kandu (Itching)	2	0	0	0
5	Vivarnata (Discoloration of Facial Skin)	2	2	1	1
6	Daha (Burning Sensation)	2	0	0	0

Before Treatment AfterTreatment

Fig 1

DISCUSSION:

The underlying cause of the illness is an imbalance in the Vata, Kapha, and Raktadoshas. Pitta has been left out because Rakta is a kind of Pittadosha. These vitiated dosh as move through out the body.Shalmali,also known as the silk cotton tree or Bombaxcebia, is the mainingredient of Shalmali gel.

It has a variety of medicinal qualities, including anti-inflammatory, antimicrobial, and cooling effects, which are useful in treating Youvanpidika(Acnevulgaris). Shalmali gel is used to treat Youvanpidika in order to minimize inflammation, manage excess oil production, and attack acne-causing microbes. It may also relieve skin irritation and promote the healing of existing acne lesions. The treatment' skey goals were to ease symptoms, improve general skin health, and improve the gel's long-term effectiveness while minimizing complaints. Shalmali gel was also standardized and tested for stability. The patient's acne lesions, discomfort, itching, burning sensations, and skin pigmentation improved dramatically after 45 days of constant application of Shalmali Gel. The gel was well-tolerated, and no side effects were recorded during treatment.The patient's general skin condition improved significantly, resulting in a healthy face texture, look and glow with youthful appearance.

Physico-chemical analysis of Shalmali gel exhibited a pleasant, translucent, and redish-brown appearance, was well-formulated with a smooth texture, ensuring uniform coverage at the application site. Visual appearance was translucent. Its skin-friendly nature was highlighted by its neutral pH of 6.8, causing no irritation during treatment. The gel's viscosity affects retention and spreading, resulting in a slower dissolution and diffusion of actives, leading to a prolonged duration of action. The Shalmali gel's non-abrasive and non-irritating nature was reinforced by its absence of irritancy.

CONCLUSION:

The research findings highlight an imbalanced state in the Vata, Kapha, and Raktadoshas as a fundamental contributor to acne vulgaris. The study under scores the effectiveness of Shalmali gel, extracted from the silk cotton tree, renowned for its anti-inflammatory, antimicrobial, and cooling attributes, as a promising remedy for this skin condition. The introduction of the innovative Shalmali gel, with its demonstrated safety and remarkable efficacy, emerges as a note worthy advancement in the management of acne vulgaris.

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Received on 27.01.2024 Revised on 22.07.2024

Accepted on 26.12.2024 Published on 03.05.2025

Available online from May 05, 2025

Asian J. Pharm. Res. 2025; 15(2):149-152.

DOI: 10.52711/2231-5691.2025.00024

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