A Cross-Sectional Survey of Raktadushti Hetu in Indralupta (Alopecia Areata) and Evaluation of the Efficacy of Jalauka Avacharana with Lepa against Platelet-Rich Plasma Therapy: An Open-Label Randomized Comparative Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- 1 Prevalence of Raktadushti Hetu in Indralupta
研究概览
简要总结
Alopecia Areata (AA), a frequent kind of Non-Scarring Alopecia affecting the body and/or scalp, is characterized by circumscribed , circular areas of hair loss , 2-5 cm in diameter that is devoid of any symptoms of inflammation. Alopecia Areata affects about 2 percent of the world’s population and 0.7 percent in India.In Ayurveda , Indralupta is understood as a Pitta-dominant Tridoshjanya Vyadhi , involving imbalances in Vata , Pitta , Kapha Dosha and Rakta Dushya . Pitta along with Vata by involving the Romakoopa causes the fall of hairs and thereafter Shleshma along with Shonita obstructs the channel of Romakoopa leading to the stoppage of the regeneration of the hair and this condition is known as Indralupta (Alopecia Areata).Treatment of Alopecia Areata is challenging, and hair loss may remit naturally, although spontaneous hair regrowth may take months to years . Traditional therapeutic modalities include Corticosteroids, Immunosuppressants, Topical Immunotherapy, and Light Therapy . Several new treatments are under investigation, including IL-2 agonist, IL-17 inhibitors, Abatacept, JAK inhibitors and Platelet-Rich Plasma (PRP). PRP is autologous preparation of platelets in concentrated plasma.It contains more than 20 growth factors.NEED OF STUDY
- The exact etiopathogenesis of Alopecia Areata is yet unknown. This research will offer an explanation regarding the prevalence of Raktadushti Hetu in Alopecia Areata, providing some preliminary evidence on Ayurvedic perspective .
- In contrast to Platelet-Rich Plasma Therapy, there isn’t enough scientific data to assess the therapeutic effectiveness of Jalauka Avacharana along with Gunja and Brahmi Lepa. This research is required to assess both treatments and offer an evidence-based comparison.
AIM AND OBJECTIVES
AIM :
To assess the prevalence of Raktadushti Hetu in patients with Indralupta and to evaluate the therapeutic efficacy of Platelet-Rich Plasma (PRP) Therapy and Jalauka Avacharana combined with Gunja and Brahmi Lepa .
OBJECTIVE :
OBSERVATIONAL STUDY :
· To document the prevalence of Raktadushti Hetu among patients attending AIIA OPD, by employing a validated assessment questionnaire.
INTERVENTIONAL STUDY :
PRIMARY OBJECTIVE
· To compare the therapeutic effect of Jalauka Avacharana in combination with Gunja Lepa and Brahmi Lepa with Platelet-Rich Plasma (PRP) Therapy in the management of Indralupta (Alopecia Areata) in terms of SALT II score .
SECONDARY OBJECTIVE
· To assess the impact of these treatment modalities on hair growth and overall clinical improvement in patients with Indralupta (Alopecia Areata).
- OUTCOME MEASURES
- PART 1 :
Prevalence (%) of Raktadushti Hetu in patients with Indralupta .
PART 2 :
PRIMARY OUTCOME : Reduction in SALT II score
SECONDRY OUTCOME :
· Reduction in size of patch
· Reduction in the number of patches
GROUPING : Participants diagnosed with Indralupta (Alopecia Areata) will be randomly allocated into two groups to compare the efficacy of Platelet-Rich Plasma (PRP) Therapy and Jalauka Avacharana (leech therapy) with sequential application of Gunja and Brahmi Lepa .
GROUP A: PLATELET-RICH PLASMA THERAPY
Patients in Group A will receive autologous PRP injections at intervals of three weeks. Each patient will undergo a total of three sittings. At each sitting, PRP will be prepared and injected into the affected scalp areas at a dose of 0.1–0.2 mL per injection site, following standard aseptic techniques.
GROUP B: JALAUKA AVACHARANA WITH GUNJA AND BRAHMI LEPA
Patients in Group B will receive Jalauka Avacharana at intervals of three weeks, with a total of three sittings. Following each Jalauka application, Gunja Lepa (as per area involved) will be applied topically over the affected scalp area for seven consecutive days, starting seven days after each Jalauka session. Subsequently, Brahmi Lepa (as per area involved) will be applied for the next seven days, immediately after the completion of Gunja Lepa application. This sequential Lepa protocol will be repeated after both the first and second Jalauka sittings.
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 45.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Patients having clinical features of Indralupta, hair loss in patches occurring anywhere on the scalp.
- •2 Patients of Indralupta with documented exposure to Raktadushti Hetu , as identified by validated questionnaire.
- •3 Patch less than 10 cm in diameter.
- •4 Number of patches 5 or less than
- •5 Platelet count more than or equal to 1.5 lacs per microlitre.
- •6 Patient with Alopecia Areata willing for the procedure Platelet-Rich Plasma therapy and Jalauka Avacharana.
排除标准
- •1 Patients who have been diagnosed with Arunshinka and Alopecia like Tinea Capitis, Trichotillomania, Telogen Effluvium, Traumatic Alopecia 2 Patients suffering from severe endocrine or systemic disease like Carcinoma, SLE, Hypertension, Hypothyroidism, Diabetes Mellitus 3 Patients taking Chemotherapy and on blood thinning medications.
- •4 Patient with Unstable Angina 5 Blood disorder like anemia, Platelet Dysfunction, Active Infections 6 Lactating and pregnant women.
- •7 Patient with history of Keloidal tendency.
结局指标
主要结局
1 Prevalence of Raktadushti Hetu in Indralupta
时间窗: Baseline(Day 0),Day 22(week 3),Day 42(week 6), Day 56(Week 8)
2 Reduction in SALT 2 Score
时间窗: Baseline(Day 0),Day 22(week 3),Day 42(week 6), Day 56(Week 8)
次要结局
- 1 Reduction in size of patch(2 Reduction in number of patches)
研究者
Dr Akriti
All India Institute of Ayurveda
