Pharmaceutico-therapeutic evaluation of gel prepared from Karpanpatru Taila and Shvitrahara Yoga on Shvitra (vitiligo)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- It is expected that the trial drugs will exert a significant action on Shvitra.
研究概览
简要总结
SUMMARY:
The clinicalstudy was aimed to evaluate clinical efficacy of gel prepared from KarpanpatruTaila and Shvitrahara Yoga in Shvitra(vitiligo).
For inclusion of patients, specializedscoring pattern for criteria of assessment was adopted. Thereafter theobservations and results are presented in tabular form followed byinterpretation. The overall assessment of therapy was deduced on the basis ofscoring pattern.
POSOLOGY& GROUPING:
Selected patients were randomly divided (byfollowing computer generated randomisation sequence) into two groups viz; groupA treated with Karpanpatru gel and group B treated with Shvitrahara**Yoga gel for local application once in a day in the morning withexposure to sunlightfor 10 minutes for 2 months. In both groups 1gm of Bakuchi Churnaand 1 gm of Vidanga Churnawasadministered orally along with honey and ghee as adjuvant. Total 111 patients were registered inthe study, out of which 100 completed the treatment.
DEMOGRAPHICDATA:
Maximum numbers of patients (78.57%)were from the age group of 16-30 years, male (58.18%), married (70.91%) andHindu (92.73%) by religion. Maximum patients were having Vata Kapha Prakriti (54.96%), Madhyama Sara(63.03%), Madhyama Satva (66.67%), Madhyama Samhanana(63.96%). Madhyama Satmya (65.77%),Madhyama Vyayama Shakti (69.37%) and Madhyama Koshta(54.55%) was found in maximum patients.
In Nidanas, Aharadominant of Guru Guna (83.78%) and Snigdha**Guna (50.45%) was found. Consumption of Viruddhahara (76.36%), Lavana+ Dugdha (22.52%), Tila-GudaSevana (57.66%), Amla Rasa + Dugdha (27.03%) and Lavana Rasa +Digdha (36.94%) was found maximum. In Vihara, Divaswapa (57.66%),Ajirna Bhojana (61.26%) and Usna**Shita Kramaviruddha Sevana(28.83%) was found maximum whereas in Vegadharana(72.07%) was dominant.
Maximum patients displayed durationof disease less than one year (30.63%) and negative family history of Shvitra (83.78%). Maximum patientsshowed symptoms of Swetabha Vaivarnyata (72.02%) and Mandalopatti (81.98%), Snigdha (65.77%), and Romavidhwansi (37.84%) of patches.Maximum patients (80%) were found white coloured patches, maximum patients(76.58%) were found more than 4 patches, (9.01%) patients were found having 1patch. 72.97% were having Avyakta Lakshnaas Purvarupa. All thepatients had Svetabha Vaivarnata as a symptom, 97.29% of patients had Anagnidagdhaas Sadhya symptoms. Asadhya Lakshana as Varshganottpana wasfound in 71.17% of the patients.
RESULTS:
Karpanpatru gel was seen toprovide better results on area score (34.38%)in left side and (35.07%) in right side of the body which is statistically significant.In number of patches, (18.97%) in left side and (18.38%) in right sideimprovement was found which is statistically significant. In Mandalottapatti,(32.91%) in left side and (35.53%) in right side improvement was found which isstatistically significant. Shvitrahara Yoga gel was seen to providebetter results on area score (22.69%) in left side and (23.06%) in right sideof the body which is statisticallysignificant. In number of patches, (10.78%) in left side and (10.95%) inright side improvement was found whichis statistically significant. In Mandalottapatti, (20.72%) inleft side and (17.14%) in right side improvement was found which is statistically significant.In between groups there are no significant difference was observed so the bothgroups are effective in the symptoms of Shvitra.
Karpanpatru gel showedmarked improvement in 14% patients, moderate improvement in 56% patients, mildimprovement in 28% patients and 2% patients showed unchanged. None of patientshowed complete remission or remarked. ShvitraharaYoga gel showed markedimprovement in 16% patients, moderate improvement in 50% patients, mildimprovement in 32% patients and 2% patients showed unchanged. None of patientshowed complete remission or remarked. No adversedrug reaction was found during study period or in follow up time.
Considering the satisfactory remarksby patients & observed; it can be concluded that trial drug can be safe andused in cases of Shvitra (vitiligo). Further, trial may be attempted onthe drug involving large sample size.
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
- 16.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- Female
入选标准
- ••Patients having signs and symptoms of Shvitra (vitiligo).
- ••Patients having Sadhya Lakshana of Shvitra.
- ••Patients having ages of 16 to 60 years.
- ••Patients with chronicity of less than 10 years.
- ••Wood’s lamp test positive.
排除标准
- •Patients having •Chronicity more than 10 years.
- ••Serious cardiac, renal, hepatic diseases, major illness like IDDM, NIDDM, patches due to burning, chemical explosion, any other serious systemic illness.
- ••Gravid and lactating women.
- ••Lesions at region of Guhyanga (genital organ), Panipadatala (sole of palm and feet), Oshtha (lips), Aekanga (particular whole organ), Sarvanga (whole body).
- ••Patches with Raktaroma (reddish hair) & Samsakta (coalescent).
结局指标
主要结局
It is expected that the trial drugs will exert a significant action on Shvitra.
时间窗: 4 weeks
次要结局
- •By providing better effect on Shvitra, the drug will effect psycho-somatic level of patient and stress condition due to disease and enhance quality of life.(2 monts)
