Assessment of manasika bhava in vyanga (melasma) and upshayatmaka effect of vatankura lepa and manjistha churna (oral) along with mantra chikitsa: an open-labeled parallel study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- • A higher prevalence of Mansika Bhava is present in vyanga (melasma).
研究概览
简要总结
One of the Kshudraroga Vyanga is distinguished by the presence of Shyavavarna bluish black
patches Niruja painless Mandalas on the face. It is among the most prevalent
conditions affecting the face. It is comparable to face melanosis one of the hyperpigmented
illnesses based on clinical characteristics. In addition to helping with Raktashodhana blood
cleansing drugs having Rakta Prasadaka Twak Prasadaka and Varnyakara qualities are
useful in the treatment of Vyanga.
Melasma is a common skin problem caused by brown to gray brown patches on the face. Most
people get it on their cheeks chin nose bridge forehead and above the upper lip. It is more
common in women than men. Pregnancy is a common cause of melasma. It also affects women
taking oral contraceptives and hormones. The prevalence of melasma is from 1 percent in the
general population to 9 to 50 percent in high risk population.
Melasma is an acquired hyper melanosis characterized by asymmetric brown coloured
irregular reticulated macules on sun exposed areas of the skin especially the face. While skin
pigmentation from sun tanning and post hyperpigmentation fades spontaneously
after the stimulus cessation in melasma this reduction usually does not occur. Melasma
evolves from alterations in several skin layers and cell types to hyper functional melanocytes
which produce and transfer mature melanosomes to the whole epidermis
Need of the study
Vyanga Melasma is a common skin disorder that often leads to significant psychological
distress among affected individuals. Conventional treatments for melasma have limited success
and may be associated with undesirable side effects. Ayurveda provides holistic approaches
for managing Vyanga focusing on both internal and external therapies.
There is currently no concrete evidence regarding the role of Manasika bhava psychological
factor in the development or management of Vyanga. However Ayurveda classics have
described regarding the etiological role of krodha and shoka in the development of vyanga.
Therefore assessing the impact of Manasika bhava and exploring integrative therapies that
combine Ayurvedic and psychological interventions may offer safer more effective and
evidence based solutions for patients.
AIM AND OBJECTIVE
AIM
To assess the role of Manasika bhava Hetu in the manifestation of vyanga Melasma and to
evaluate the clinical efficacy of Vatankura Lepa and Manjishtha churna along with Mantra
chikitsa in its management.
OBJECTIVES
PRIMARY OBJECTIVE
To assess the prevalence of Manasika bhavas in the manifestation of Vyanga
Melasma.
To evaluate the therapeutic Upshayatmaka effect of Vatankura Lepa in combination
with Manjishtha churna and add on effect of Mantra Chikitsa on Vyanga Melasma.
SECONDARY OBJECTIVES
To evaluate the therapeutic effect along with Mantra chikitsa on serum cortisol level
and fMRI EEG electroencephalogram if facility available in AIIA.
Expected outcome
PRIMARY OUTCOME
A higher prevalence of Mansika Bhava is present in vyanga Melasma.
Change in MASI Melasma Area and Severity Index SCALE after the treatment
Improvement and resolution in sign and symptoms of Vyanga Melasma.
SECONDARY OUTCOME
Change in serum cortisol level alpha MSH IgE level EEG fMRI.
Change in Perceived stress scale.
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
- 18.00 Year(s) 至 38.00 Year(s)(—)
- 性别
- All
入选标准
- •patient diagnosed with vyanga (melasma) on the basis of clinical signs and symptoms.
- •patient willing to give written informed consent and follow up.
- •Patients of age group 18-38 years irrespective of sex, religion, or occupation.
- •Disease chronicity not more than 5 yr.
- •patients with controlled hypothyroidism and diabetes.
- •patient of vyanga showing the presence of Manasika bhava in any grade.
排除标准
- •Pregnant women and lactating mothers.
- •Patients below 18 years and above 38 yr of age.
- •Severe dermatological disorders (e.g., eczema, psoriasis).
- •Patient with uncontrolled hypothyroidism (TSH Greater than 5mIU/L) and diabetes (HbA1c More than 6.5%).
- •Patient on hormonal therapy.
- •Patient not willing to participate in clinical trial.
- •Patient with any hearing impairment.
结局指标
主要结局
• A higher prevalence of Mansika Bhava is present in vyanga (melasma).
时间窗: for an interventional study | Percentage change of the clinical sign and symptoms of vyanga in both the groups after 45 days i.e. follow up 2 months and observing the effect of drugs on manasika bhava
• Change in MASI (Melasma Area and Severity Index) SCALE after the treatment.
时间窗: for an interventional study | Percentage change of the clinical sign and symptoms of vyanga in both the groups after 45 days i.e. follow up 2 months and observing the effect of drugs on manasika bhava
• Improvement/resolution in signs and symptoms of Vyanga (Melasma).
时间窗: for an interventional study | Percentage change of the clinical sign and symptoms of vyanga in both the groups after 45 days i.e. follow up 2 months and observing the effect of drugs on manasika bhava
次要结局
- To evaluate the therapeutic effect along with Mantra chikitsa on serum cortisol level,(and fMRI, EEG (electroencephalogram) (if the facility is available in AIIA).)
研究者
Dr Devashish
ALL INDIA INSTITUTE OF AYURVEDA
