“An Open Randomized Comparative Clinical Study of Vamanottara Jalaukavacharana and Jalaukavacharana in the Management of Mandal Kushtha w.s.r. to Psoriasisâ€
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of changes in specific signs and symptoms of Mandal Kushtha (psoriasis).
研究概览
简要总结
Introduction:
Psoriasis is chronic inflammatory skin disorder clinically characterized by erythematous, sharply demarcated papules and rounded plaques. Since characteristics features of psoriasis are much closer to Mandal Kushtha hence Mandal Kushtha can be compared with psoriasis. Mandal Kushtha is Kapha predominant disease. The etiology of Mandal Kushtha can be understood on the basis of general etiology of Kushtha. Swetarakta (faint reddish white), Utsannamandalam (raised patches), Sthiram (stable), Snigdham (unctous), A*nnyonyasansaktm (*patches joined with each other) are important clinical features of Mandal Kushtha.Although there are advancements in the management of psoriasis still it is challenge to treat due to recurrent nature. Prevalence of psoriasis ranges between 0.09% and 11.5%. Prevalence in India is 0.44 – 2.2%, with average incidence of 2.2%.As mentioned by Acharya Charaka “Bahudosha Samsodhya……..â€. There is a need of study to rule out the effective, safer and economical methods of Dosha Sodhana for the management of Mandal Kushtha. There is also need to evaluate the comparative efficacy of different types of Sodhana Karma based on the predominance Dosha for the better management of diseases.
Materials and Methods:
30 patients suffering from Mandal Kushtha(psoriasis) attending OPD and IPD section of NIA, Jaipur (Raj) fulfilling the inclusion criteria of the study were randomly selected, irrespective of religion, occupation and socio-economic status. Patients were randomly divided into two groups (15 patients in each group). In Group A Vamana Karma followed by Jalaukavacharana was done in 15 patients and in Group B only Jalaukavacharana was donein 15 patients.
Vamana procedure - First of all Deepana, Pachana with Panchakol Choorna (3 gm) twice a day before food till appearance of Nirama Lakshana was given. Snehapana with Go-Ghrita for 3-7 days as per Kostha was done till the appearance of Samyaka Snigdha Lakshana. Sarvanga Abhyanga by Dashamoola Taila and Sarvanga Swedana by the Dashamoola Kwatha was done for 2 days. Vamana was induced by administrating Vamaka Yoga.After Vamana Karma, Dhoompana was done followed by Samsarjana Karma as per the type of Shuddhi.
Jaluakavacharan procedure**-**Affected part were made free from any ointment, application of local Swedana (Nadi Swedana ) was done. Patients were given 4 seating of Jalaukavacharana once per week. 6 Jalauka was applied (2 on upper extremities, 2 on lower extremities, 2 on trunk and head region) and Jalauka was be reused only for the same patient. Removal of Jalauka, Vamana of Jalauka, labelling of Jaluaka container was done in proper way. Dressing up was done and cotton bandages were used.
**TRIAL DRUGS-Deepan Paachan drugs-***Panchakol Choorna(A.H.Su 6/166).*Drugs of Jeemutak Yoga for Vamana Karma. Vamanopag drugs- Madhuyashtiphanta (Glycyrrhiza glabra).
PASIscore was used as the objective parameter. Assessment was done on the basis of PASI and Ayurveda parameter before treatment, after treatment and during last follow up.
Result:
Wilcoxan Rank Sum test and Mann-Whitney test were used for the statistical analysis.
Effect on Mandal Roopa:
The study shows that Group A (Vamana Karma followed by Jalauakavacharana) provided very significant (p<0.05) results in Mandal Roopa with percentage of relief by 20.35% after treatment and on follow-up, it shows very significant relief of 26.54% with p value (p<0.05) in within group comparison. Group B (Jalauakavacharana) provided relief by 2.43% in Mandal Roopa after treatment which is statistically not significant (p>0.05) and on follow-up also, it shows non-significant result with p value (p>0.05) with relief of only 8.13%. Thus both group have efficacy on Mandal Roopa but Group A patient shows marked improvement. Inter group comparison shows that statistically there is no any significant between Group A and Group B. But we can found marked difference in mean rank sum of both groups. Mean rank of Mandal Roopa (18.10) in Group A is greater than that of mean rank of Mandal Roopa (12.90) in Group B.
Effect on Kandu:
Present study shows that in group A (Vamana Karma followed by Jalauakavacharana) provided extremely significant variation with percentage of relief by 48.71% after treatment In group B (Jalauakavacharana) provided extremely significant variation with percentage of relief by 45.45% after treatmen
Hence both the group has shown extremely significant effect in the Kandu parameter when compared within group.
Inter group comparison shows that statistically there is no any significant between Group A and Group B. Mean rank of Kandu (18.00) in Group A is greater than that of mean rank of Kandu (13.00) in Group B. Thus, based on mean rank we can say that Group A is slightly more effective than Group B on reducing the Kandu in psoriasis patients.
Effect on Chinta:
Present study shows that Group A (Vamana Karma followed by Jalauakavacharana) provided extremely significant (p<0.001) results in Chinta with percentage of relief by 39.91% after treatment and on follow-up, it showed extremely significant (p<0.001) results with relief of 45.92%. Group B (Jalauakavacharana) provided relief by 10.75% in Chinta after treatment which is statistically not significant (p>0.05) and on follow-up also, it shows non-significant result with p value (p>0.05) with same relief of only 10.75%.
Inter group comparison shows that there is very significant variation in both groups after treatment in the parameter of Chinta (p<.001). Group A is found more effective than Group B. Stress is a common trigger for psoriasis disease.
Effect on PASI:
This study shows that after treatment on group A (Vamana Karma followed by Jalauakavacharana) showed very significant (p=0.001) results in PASI Scorewith percentage of relief by 46.75% after treatment and on follow-up also, it shows very significant relief of 56.38% with p value (p=0.001).
Thus, within-group comparison shows that both the group have significant improvement on PASI.
Whereas intergroup comparison shows that there is significant variation in both groups after treatment in the parameter of PASI Score.
The Group A (mean rank 20.07) has shown significant decrease in the PASI Score than group B (mean rank 10.93).
Conclusion:
Group A (Vamana Karam followed by Jalaukavacharana) is more effective than Group B, thus null hypothesis is rejected and alternative hypothesis is accepted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •a)Patients between 18 to 60 years of age.
- •b)Patients with the classical features of Mandal Kushtha (psoriasis).
- •c)Patients not taking any other medicine for Mandal Kushtha (psoriasis).
- •d)Patients fit for Vamana and Jalaukavacharana.
- •e)Patients willing to sign consent form for trial.
排除标准
- •1.Pregnant women and lactating mothers.
- •2.Patients suffering from systemic disorders as Cardiac Problem, Uncontrolled Diabetes mellitus, Uncontrolled Hypertension, Paralysis, Malignancy, HIV, HBsAg, Leprosy.
- •3.Patients unfit for Vamana karma and Jalaukavacharana.
结局指标
主要结局
Assessment of changes in specific signs and symptoms of Mandal Kushtha (psoriasis).
时间窗: 60 days
次要结局
- A Any adverse effect in the values of hematological test and in clinical signs and symptoms.(60 days)
