A Clinical Trial to Study the Effect of Wet and Dry Dadima Fruit Peel In Melasma

Phase 2

Recruiting

• Conditions: Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VYANGAH,

• Registration Number: CTRI/2023/09/058009
• Lead Sponsor: Dr Safiya Falak

Brief Summary

**BRIEF RESUME OF THE INTENDED WORK:**

**NEED FOR THE STUDY**

Beauty is a subject of socio-medical importance since ancient times. As time passes the importance and demand for beautification also increased. But, few facial disorders are still a problem which damages beauty, among themmelasma is one.

Melasma is a chronic acquired hypermelanosis of skin characterized by irregular brown patches symmetrically distributed on sun exposed area particularly on face1. Due to its frequent facial involvement, the disease has an impact on quality of life of a person and is a cause of psychologicaldistress.

The melasma affects both gender, but a clear female predominance was observed. The prevalence rate of melasma varies from 1.5% to 33.3%, depending on the population2. It’s pathology is not yet completely understood, although there are some known factors such as excessive sun exposure, inflammatory process of skindue to irritants, pregnancy, use of oral contraceptive pills, cosmetics, steroids, etc are responsible for over production of melanin pigment in skin causing melasma3.

In contemporary science most effectivetherapy for melasma includes combination of topical agents and oral medications, such as hydroquinone, tretinoin and tranexamic acid, etc4.

In Ayurveda melasma may be compared with vyanga, which is caused by the vitiation of vata and pitta dosha, and is characterized by neeruja, tanu, shyava varnayukta mandala on mukha pradesha5.

In Ayurveda, different treatment modalities are mentioned for the management of vyanga such as raktamokshana, varnyakaradravyalepa etc. And there are many varnyadravyas are mentioned for vyanga such as Manjishtha, Arjuna, Lodhra, Dadima, etc6.

Among these Dadima (*Punica granatum* Linn) phala twak is one, which is non-controversial, easily available and cost-effective, posses the properties like madhura, kashaya, amla rasa, laghu,snigdhaguna, anushnaveerya, madhuravipaka and act as varnyakara, grahi, hridya, etc7.

According to classics, the Dadima phala twak is advised to be used in Ardra (wet) form along with goat’s milk in the management of vyanga8. But the fruit is not available in all seasons. Hence, an attempt will be made to evaluate and compare the efficacy of both Ardra (wet) and Shushka (dry) Dadima phala twak lepa in the vyanga by clinical trial.

**OBJECTIVES OF THE STUDY:**

1.      To study pharmacognostical and phytochemical characters of Ardra and Shushka Dadima phala twak (*Punica granatum* Linn).

2.      To evaluate and compare the efficacy of Ardra andSushkaDadimaphalatwaklepa in vyanga.**Research Design**

1.      **Study Design:** Pharmacognostical and open labelled two armed clinical trial.

2.      **Sample Size:** 30 subjects of vyanga (melasma).

3.      **Selection Criteria:** Diagnosed subjects of vyanga will be selected on the basisof simple randomized sampling procedure by preparing special case proforma.

4.      **Duration:** 30 days.

5.      **Grouping****:** **30** subjects will be allocated into two groups, consisting of 20 subjectsin each group.

**Group-I**: Trial group will be treated with Ardra Dadima Phala twak lepa.

**Group-II:** Trial group will be treated with Shushka Damida Phala twak lepa.

**6. PARAMETERS:**

1) **SUBJECTIVE CRITERIA:**

a.       Shyavavarnata

b.      Kandu

**2) OBJECTIVE CRITERIA:**

a.       Number of patches

b.      Area of pigmentation

**INCLUSIONCRITERIA:**

1.      18-50 years of subjects, irrespective of gender.

2.      Acute cases of melasma (<1year).

3.      Area-Nose, cheeks, upperchin, forehead.

**EXCLUSIONCRITERIA:**

1.      Chronic cases more than >2year.

2.      Associatedwithanyserioussystemicdisorder.

3.      Historyofallergytotopicalapplications.

4.      Pregnancy induced melasma.

5.      SkinCancer.

**7. INTERVENTION CHART:**

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

|**Sl. No**

**Group**

**Test Drug**

**Part Used**

**Route of Administration and Form**

**No. of Patients**

**Dose**

**Base**

**Duration**

|1

I

ArdaDadimaphala

Twak

Lepa

15

Q.S.

Goat’s Milk

30 days

|2

II

ShushkaDadimaphala

Twak

Lepa

15

Q.S.

Goat’s Milk

30 days

3) **MSI Score:Melasma Severity Index**

**Formula: MSI** = 0.4(a×p2)l+0.4(a×p2)r+0.2(a×p2)n or **MSI** = a×p2

Where; a = area of involvement, p = severity of pigmentation, l = left face, r = right face, n = nose

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-10
• Last Update Posted: 2024-12-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1.18-50 years of subjects, irrespective of gender.
• 2.Acute cases of melasma (<1year).
• 3.Area-Nose, cheeks, upperchin, forehead.

Exclusion Criteria

• 1.Chronic cases more than >2year.
• 2.Associatedwithanyserioussystemicdisorder.
• 3.Historyofallergytotopicalapplications.
• 4.Pregnancy induced melasma.
• 5.SkinCancer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in	0 Day, 15 Day, 30 Day and 45 Day
a.Shyavavarnata	0 Day, 15 Day, 30 Day and 45 Day
b.Kandu	0 Day, 15 Day, 30 Day and 45 Day
c.Number of patches	0 Day, 15 Day, 30 Day and 45 Day
d.Pigmentation	0 Day, 15 Day, 30 Day and 45 Day

Secondary Outcome Measures

Name	Time	Method
Improvement in MSI Score and colour and compexion	0 Day, 15 Day, 30 Day and 45 Day

Trial Locations

Locations (1)

Sri Siddharudh Charitable Hospital; 🇮🇳 Bidar, KARNATAKA, India

Sri Siddharudh Charitable Hospital

🇮🇳Bidar, KARNATAKA, India

Dr Safiya Falak

Principal investigator

9513277277

drsafiyafalak@gmail.com