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临床试验/CTRI/2026/01/101781
CTRI/2026/01/101781尚未招募2/3 期

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

All India Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年1月27日最近更新:

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

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Devashish

ALL INDIA INSTITUTE OF AYURVEDA

研究点 (1)

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