Pharmaceutical standardization of two different dosage form of Apamarg Kshara Yoga and Their clinical efficacy on Shvitra(vitiligo)

Brief summary for CTRI

SUMMARY:

Theclinical study was aimed to evaluate clinical efficacy of Apamarga Kshara Yoga’s Lepa and ointment form in Shvitra (vitiligo).

For inclusion ofpatients, specialized scoring pattern for criteria of assessment was adopted.Thereafter the observations and results are presented in tabular form followedby interpretation. The overall assessment of therapy was deduced on the basisof scoring pattern.

POSOLOGY & GROUPING:

Selectedpatients were randomly divided (by following computer generated randomisationsequence) into two groups viz; group A treated with Apamarga Kshara Yoga Lepaand group B treated with Apamarga Kshara Yoga ointment for local application once in a day in the morning withexposure to sunlightfor 10 minutes for 2 months. In both groups 3gm of Rasayana Churna was administered orally along with honey and ghee as adjuvant.Total 55 patients were registered inthe study, out of which 50 completed the treatment.

DEMOGRAPHIC DATA:

Maximum numbersof patients (47.26%) were from the age group of 16-30 years, male (54.55%),unmarried (65.45%) and Hindu (92.73%) by religion. Maximum patients were havingVata Kapha Prakriti(40%), Madhyama Sara (65.46%), Madhyama Satva(56.36%), Madhyama Samhanana (72.73%). Madhyama Pramana(65.45%), Madhyama Satmya(67.27%), Madhyama Vyayama Shakti (56.36%), Mandagni (49.09%) and Madhyama Koshta(70.90%) was found in maximum patients.

In Nidanas,Ahara was dominant in Guru(88.89%) and Snigdha Guna (74.07%) and Sheeta (81.41%). Consumptionof Viruddhahara (76.36%), Rasona or Plandu + Dugdha (47.27%)and Drava-Snighdha-Guru-Ahara Seavana (47.27%) was found maximum. In Vihara, Divaswapa(81.82%) and Usna Shita Kramaviruddha Sevana(47.27%) was found maximum whereas in Vegadharana(74.55%) was dominant.

Maximumpatients displayed duration of disease less than one year (29.09%) and have negativefamily history of Shvitra (80%).Maximum patients showed symptoms of Swetabha**Vaivarnyata and Mandalopatti (100%), Rukshata(49.09%), and Bahala (34.55%) ofpatches.

Maximumpatients (80%) were found white coloured patches, and most (54.55%) were found tohave more than 4 patches, maximum patients (38.18%) were found 2% involved areaof the body, maximum patients (40%) were found more than 4 cm size of patchesand maximum patients (52.73%) were found in moderately disease condition.

RESULTS:

Apamarga KsharaYoga Lepa was seen to provide better results on colour ofpatches (57.26%), Number of patches (43.80%), area of patches (40.58%) and sizeof patches (42.42) where in Apamarga Kshara Yoga ointment shows betterresults on colour of patches (55.36%), Number of patches (40.20%), area ofpatches (35.53%) and size of patches (42.45). Both groups were observed toexhibit statistically highly significant results on colour, number, area andsize of patches.No ADRs found during clinical study.

Apamarga**Kshara Lepa showed moderate improvement in 52% patients, mildimprovement in 32% and 16% patients showed unchanged. None of patients showedmarked improvement and complete remission. In Apamarga Kshara Yogaointment, 52% patients showed moderate improvement, 36% patients showed mildimprovement and 12% patients were unchanged. None of the treated patientsshowed marked improvement or complete remission in both groups.

Considering thesatisfactory remarks by patients & observed; it can be concluded that thetrial drug can be safe and used in cases of Shvitra (vitiligo). Further,trial may be attempted on the drug involving large sample size.