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Modification of Jivantyadi Yamaka into Malahara and its Clinical Efficacy in Psoriasis

Completed
Conditions
Diseases of the skin and subcutaneous tissue. Ayurveda Condition: EKAKUSHTHAH,
Registration Number
CTRI/2021/04/032979
Lead Sponsor
Government Ayurved Hospital Vadodara
Brief Summary

Clinical study was carried out after permission frominstitutional ethics committee clearance(GAV/VAD/IEC/60/2020, Dated 20/08/2020) and retrospectively registered atClinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2021/04/032979[Registered on 20 / 04 /2021]. Study type was interventional, openlabel randomized clinical trial. It explores with description of the aims and objectives,materials and methods, criteria of selection of the patients, general observationsand effect of therapy. Also a detailed description about the diagnosticcriteria for psoriasis along with the subjective and objective criteria for theassessment of results is stated here. Specialized scoring pattern for criteriafor assessment was adopted were assessed in terms of percentage relief andstatistical evaluation. Thereafter the observations and results are presentedin tabular form followed by interpretation. The overall assessment of therapywas decided on the basis of scoring pattern. In this study, total 35 patientswere selected and randomly divided into two groups, 16 in group A and 19 ingroup B respectively. Total 30 patients i.e. 15 in group A and 15 in group Bcompleted the treatment with JY and JM respectively. Duration of treatment was4 weeks along with follow up of 1 week. The observations were made on theparameters like age, sex, occupation, addiction etc. and cardinal symptoms like*Matsyashakalopamam, Krishna Aruna Varna, Mahavastu, Mandala, Aswedanama*etc., scrutinized, analyzed and recorded through a specially prepared proforma.The effect of all the drugs on signs and symptoms of disease, haematocritvalues were recorded before and after treatment by adopting scoring pattern.

Maximum numbers ofpatients (42.86%) were from the age group of 51-60 years, male (65.71%),married (94.29%) and Hindu (82.86%) by religion. Maximum patients were having *Kapha**Vata* *Prakriti* (57.14%), *Rajasika Manasa Prakriti,* *Madhyama**Satva* (62.86%), *Madhyama* *Samhanana* (100%), *Madhyama Pramana*(100%), *Madhyama* *Satmya* (94.28%), *Madhyama* *Vyayama* *Shakti*(65.71%), *Madyama Abhyavarana Shakti* (97.14%) and *Madhyama* *Koshtha*(80%) were found in maximum patients.

*Amla Rasa*(82.86%) *Pradhana Ahara sevana* was found in maximum of patients asetiological factor. *Ahara* dominant in *Guru* (82.86%) and *Sheeta**Guna* (54.28%) was dominant majority of enrolled. consumption of *ViruddhaAhara* (60%) followed by *Pishtanna* (57.14%) was found maximum.

Maximum patients developedthe disease less than a year (68.57%) and a negative family history ofpsoriasis was found in (91.43%). Maximum patients showed symptoms of *Kandu*(100%), *Matsyashakalopama* (94.28%), *Krishna-Aruna Varna* (88.57%),and *Nidranasha* (54.29%).

Group A shows highlysignificant result was found` in *Matsyashakalopama, Krishna-Aruna Varna* and*Kandu*, while significant resultwas found in *Rukshata.* In group B highly significant result wasfound in *Kandu*, while significant result was found in *Matsyashakalopama,Krishna-Aruna Varna, Rukshata, Nidranasha,.* Group A was seen to providebetter results on complaints *Kandu* (86.67%), *Matsyashakalopama*(73.33%)*,* *Rukshata* (43.33%) and *Krishna-ArunaVarna* (30%)where in group B shows better result on *Nidranasha* (46.67%).Insignificant result was found in *Aswedanama, Mahavastu, Mandala, Daha* and *Srava* in both groups.In Both grouphighly significant result was found in PASIand DLQI score, while in both group significant result was found in Auspitzsign.

The variations observed in haematological parametersbefore and after treatment were statistically insignificant in both groups.

Datareveals that group A and group B showed statistically insignificant differencein appearance of all sign of *Ekakushtha* except *Kandu,* group Ashows better result in *Kandu* than group B. In group A and group B,73.33% and 20% of the patients showed moderate improvement while mildimprovement were seen in 20% and 60% of patients respectively. There is 6.66%patients showed marked improvement in group Abut there is no patient showedmarked improvement in group B. Unchanged result was found in 20% patients ingroup B. There is none patient was observed for complete remission in group Aand B.

Clinical study was carried out after permission frominstitutional ethics committee clearance(GAV/VAD/IEC/60/2020, Dated 20/08/2020) and retrospectively registered atClinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2021/04/032979[Registered on 20 / 04 /2021]. Study type was interventional, openlabel randomized clinical trial. It explores with description of the aims and objectives,materials and methods, criteria of selection of the patients, general observationsand effect of therapy. Also a detailed description about the diagnosticcriteria for psoriasis along with the subjective and objective criteria for theassessment of results is stated here. Specialized scoring pattern for criteriafor assessment was adopted were assessed in terms of percentage relief andstatistical evaluation. Thereafter the observations and results are presentedin tabular form followed by interpretation. The overall assessment of therapywas decided on the basis of scoring pattern. In this study, total 35 patientswere selected and randomly divided into two groups, 16 in group A and 19 ingroup B respectively. Total 30 patients i.e. 15 in group A and 15 in group Bcompleted the treatment with JY and JM respectively. Duration of treatment was4 weeks along with follow up of 1 week. The observations were made on theparameters like age, sex, occupation, addiction etc. and cardinal symptoms like*Matsyashakalopamam, Krishna Aruna Varna, Mahavastu, Mandala, Aswedanama*etc., scrutinized, analyzed and recorded through a specially prepared proforma.The effect of all the drugs on signs and symptoms of disease, haematocritvalues were recorded before and after treatment by adopting scoring pattern.

Maximum numbers ofpatients (42.86%) were from the age group of 51-60 years, male (65.71%),married (94.29%) and Hindu (82.86%) by religion. Maximum patients were having *Kapha**Vata* *Prakriti* (57.14%), *Rajasika Manasa Prakriti,* *Madhyama**Satva* (62.86%), *Madhyama* *Samhanana* (100%), *Madhyama Pramana*(100%), *Madhyama* *Satmya* (94.28%), *Madhyama* *Vyayama* *Shakti*(65.71%), *Madyama Abhyavarana Shakti* (97.14%) and *Madhyama* *Koshtha*(80%) were found in maximum patients.

*Amla Rasa*(82.86%) *Pradhana Ahara sevana* was found in maximum of patients asetiological factor. *Ahara* dominant in *Guru* (82.86%) and *Sheeta**Guna* (54.28%) was dominant majority of enrolled. consumption of *ViruddhaAhara* (60%) followed by *Pishtanna* (57.14%) was found maximum.

Maximum patients developedthe disease less than a year (68.57%) and a negative family history ofpsoriasis was found in (91.43%). Maximum patients showed symptoms of *Kandu*(100%), *Matsyashakalopama* (94.28%), *Krishna-Aruna Varna* (88.57%),and *Nidranasha* (54.29%).

Group A shows highlysignificant result was found` in *Matsyashakalopama, Krishna-Aruna Varna* and*Kandu*, while significant resultwas found in *Rukshata.* In group B highly significant result wasfound in *Kandu*, while significant result was found in *Matsyashakalopama,Krishna-Aruna Varna, Rukshata, Nidranasha,.* Group A was seen to providebetter results on complaints *Kandu* (86.67%), *Matsyashakalopama*(73.33%)*,* *Rukshata* (43.33%) and *Krishna-ArunaVarna* (30%)where in group B shows better result on *Nidranasha* (46.67%).Insignificant result was found in *Aswedanama, Mahavastu, Mandala, Daha* and *Srava* in both groups.In Both grouphighly significant result was found in PASIand DLQI score, while in both group significant result was found in Auspitzsign.

The variations observed in haematological parametersbefore and after treatment were statistically insignificant in both groups.

Datareveals that group A and group B showed statistically insignificant differencein appearance of all sign of *Ekakushtha* except *Kandu,* group Ashows better result in *Kandu* than group B. In group A and group B,73.33% and 20% of the patients showed moderate improvement while mildimprovement were seen in 20% and 60% of patients respectively. There is 6.66%patients showed marked improvement in group Abut there is no patient showedmarked improvement in group B. Unchanged result was found in 20% patients ingroup B. There is none patient was observed for complete remission in group Aand B.

Clinical study was carried out after permission frominstitutional ethics committee clearance(GAV/VAD/IEC/60/2020, Dated 20/08/2020) and retrospectively registered atClinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2021/04/032979[Registered on 20 / 04 /2021]. Study type was interventional, openlabel randomized clinical trial. It explores with description of the aims and objectives,materials and methods, criteria of selection of the patients, general observationsand effect of therapy. Also a detailed description about the diagnosticcriteria for psoriasis along with the subjective and objective criteria for theassessment of results is stated here. Specialized scoring pattern for criteriafor assessment was adopted were assessed in terms of percentage relief andstatistical evaluation. Thereafter the observations and results are presentedin tabular form followed by interpretation. The overall assessment of therapywas decided on the basis of scoring pattern. In this study, total 35 patientswere selected and randomly divided into two groups, 16 in group A and 19 ingroup B respectively. Total 30 patients i.e. 15 in group A and 15 in group Bcompleted the treatment with JY and JM respectively. Duration of treatment was4 weeks along with follow up of 1 week. The observations were made on theparameters like age, sex, occupation, addiction etc. and cardinal symptoms like*Matsyashakalopamam, Krishna Aruna Varna, Mahavastu, Mandala, Aswedanama*etc., scrutinized, analyzed and recorded through a specially prepared proforma.The effect of all the drugs on signs and symptoms of disease, haematocritvalues were recorded before and after treatment by adopting scoring pattern.

Maximum numbers ofpatients (42.86%) were from the age group of 51-60 years, male (65.71%),married (94.29%) and Hindu (82.86%) by religion. Maximum patients were having *Kapha**Vata* *Prakriti* (57.14%), *Rajasika Manasa Prakriti,* *Madhyama**Satva* (62.86%), *Madhyama* *Samhanana* (100%), *Madhyama Pramana*(100%), *Madhyama* *Satmya* (94.28%), *Madhyama* *Vyayama* *Shakti*(65.71%), *Madyama Abhyavarana Shakti* (97.14%) and *Madhyama* *Koshtha*(80%) were found in maximum patients.

*Amla Rasa*(82.86%) *Pradhana Ahara sevana* was found in maximum of patients asetiological factor. *Ahara* dominant in *Guru* (82.86%) and *Sheeta**Guna* (54.28%) was dominant majority of enrolled. consumption of *ViruddhaAhara* (60%) followed by *Pishtanna* (57.14%) was found maximum.

Maximum patients developedthe disease less than a year (68.57%) and a negative family history ofpsoriasis was found in (91.43%). Maximum patients showed symptoms of *Kandu*(100%), *Matsyashakalopama* (94.28%), *Krishna-Aruna Varna* (88.57%),and *Nidranasha* (54.29%).

Group A shows highlysignificant result was found` in *Matsyashakalopama, Krishna-Aruna Varna* and*Kandu*, while significant resultwas found in *Rukshata.* In group B highly significant result wasfound in *Kandu*, while significant result was found in *Matsyashakalopama,Krishna-Aruna Varna, Rukshata, Nidranasha,.* Group A was seen to providebetter results on complaints *Kandu* (86.67%), *Matsyashakalopama*(73.33%)*,* *Rukshata* (43.33%) and *Krishna-ArunaVarna* (30%)where in group B shows better result on *Nidranasha* (46.67%).Insignificant result was found in *Aswedanama, Mahavastu, Mandala, Daha* and *Srava* in both groups.In Both grouphighly significant result was found in PASIand DLQI score, while in both group significant result was found in Auspitzsign.

The variations observed in haematological parametersbefore and after treatment were statistically insignificant in both groups.

Datareveals that group A and group B showed statistically insignificant differencein appearance of all sign of *Ekakushtha* except *Kandu,* group Ashows better result in *Kandu* than group B. In group A and group B,73.33% and 20% of the patients showed moderate improvement while mildimprovement were seen in 20% and 60% of patients respectively. There is 6.66%patients showed marked improvement in group Abut there is no patient showedmarked improvement in group B. Unchanged result was found in 20% patients ingroup B. There is none patient was observed for complete remission in group Aand B.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
30
Inclusion Criteria

Patients with all forms of Ekakushtha (Psoriasis) with classical signs & symptoms of Ekakushtha (Psoriasis) All type of psoriasis will be included Less than 20 % involved area according to PASI guidelines.

Exclusion Criteria
  • More than 20 % involved area according to PASI guidelines Age <18yrs and >60yrs.
  • Pregnant women and lactating mother Uncontrolled Diabetes Mellitus & Hypertension Any other serious systemic illness like AIDS, Malignancy etc •Patients who are not willing to be included in the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in the Classical Symptoms of Ekakushtha (Psoriasis)35 days
Secondary Outcome Measures
NameTimeMethod
Difference in Clinical efficacy of Jivantyadi Yamaka and Malahara in Ekakushtha (Psoriasis)35 days

Trial Locations

Locations (1)

Government Ayurved Hospital, Vadodara

🇮🇳

Vadodara, GUJARAT, India

Government Ayurved Hospital, Vadodara
🇮🇳Vadodara, GUJARAT, India
Dr Shivani P Vyas
Principal investigator
9979927601
vyasshivani96@gmail.com

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