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CTRI Number  CTRI/2021/04/032979 [Registered on: 20/04/2021] Trial Registered Prospectively
Last Modified On: 07/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Modification of Jivantyadi Yamaka into Malahara and its Clinical Efficacy in Psoriasis 
Scientific Title of Study   Pharmaceutical Development of Jivantyadi Yamaka into Malahara and their Comparative Clinical Efficacy in Ekakustha (Psoriasis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivani Pareshkumar Vyas 
Designation  M.D. Scholar 2nd year 
Affiliation  Government Ayurved College, Vadodara 
Address  Post graduate department of Rasashastra and Bhaishajya Kalpana Government Ayurved College, Ajwa road, Dhanvantari marg,Panigate

Vadodara
GUJARAT
390019
India 
Phone  9979927601  
Fax    
Email  vyasshivani96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharti Umretia 
Designation  Assistant Professor 
Affiliation  Government Ayurved College, Vadodara 
Address  Post graduate department of Rasashastra and Bhaishajya Kalpana Government Ayurved College, Ajwa road, Dhanvantari marg,Panigate

Vadodara
GUJARAT
390019
India 
Phone  7600011944  
Fax    
Email  dr.bhartiumrethia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kruti Vyas 
Designation  Assistant Professor 
Affiliation  Government Ayurved College, Vadodara 
Address  Post graduate department of Rasashastra and Bhaishajya Kalpana Government Ayurved College, Ajwa road, Dhanvantari marg,Panigate

Vadodara
GUJARAT
390019
India 
Phone  9426393726  
Fax    
Email  vyas_krt@yahoo.co.in  
 
Source of Monetary or Material Support  
Government Ayurved College and Hospital,Ajwa road, Dhanvantari marg, Panigate, Vadodara-390019 
 
Primary Sponsor  
Name  Government Ayurved Hospital Vadodara 
Address  Government Ayurved Hospital, Ajwa road,Dhanvantari Marg, Panigate, Vadodara-390019 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivani P Vyas  Government Ayurved Hospital, Vadodara  OPD and IPD,Rasashastra and Bhaishajya Kalpana Department
Vadodara
GUJARAT 		 9979927601

vyasshivani96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: EKAKUSHTHAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Jivantyadi Malahara (JM) and placebo  Jivantyadi Malahara OD - at night [Quantity sufficient for local application of affected part of the body] Placebo 2 capsules BD- after meal 
Intervention  Jivantyadi Yamaka and placebo  Jivantyadi Yamaka OD - at night [Quantity sufficient for local application of affected part of the body] Placebo 2 capsules BD- after meal 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in the Classical Symptoms of Ekakushtha (Psoriasis)  35 days 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in Clinical efficacy of Jivantyadi Yamaka and Malahara in Ekakushtha (Psoriasis)   35 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2021 
Date of Study Completion (India) 18/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Clinical study was carried out after permission from institutional ethics committee clearance (GAV/VAD/IEC/60/2020, Dated 20/08/2020) and retrospectively registered at Clinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2021/04/032979 [Registered on 20 / 04 /2021]. Study type was interventional, open label randomized clinical trial. It explores with description of the aims and objectives, materials and methods, criteria of selection of the patients, general observations and effect of therapy. Also a detailed description about the diagnostic criteria for psoriasis along with the subjective and objective criteria for the assessment of results is stated here. Specialized scoring pattern for criteria for assessment was adopted were assessed in terms of percentage relief and statistical evaluation. Thereafter the observations and results are presented in tabular form followed by interpretation. The overall assessment of therapy was decided on the basis of scoring pattern. In this study, total 35 patients were selected and randomly divided into two groups, 16 in group A and 19 in group B respectively. Total 30 patients i.e. 15 in group A and 15 in group B completed the treatment with JY and JM respectively. Duration of treatment was 4 weeks along with follow up of 1 week. The observations were made on the parameters 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, haematocrit values were recorded before and after treatment by adopting scoring pattern.

Maximum numbers of patients (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 as etiological factor. Ahara dominant in Guru (82.86%) and Sheeta Guna (54.28%) was dominant majority of enrolled. consumption of Viruddha Ahara (60%) followed by Pishtanna (57.14%) was found maximum.

Maximum patients developed the disease less than a year (68.57%) and a negative family history of psoriasis 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 highly significant result was found` in Matsyashakalopama, Krishna-Aruna Varna and Kandu, while significant result was found in Rukshata. In group B highly significant result was found in Kandu, while significant result was found in Matsyashakalopama, Krishna-Aruna Varna, Rukshata, Nidranasha,. Group A was seen to provide better results on complaints Kandu (86.67%), Matsyashakalopama (73.33%), Rukshata (43.33%) and Krishna-Aruna Varna (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 group highly significant result was found in PASI and DLQI score, while in both group significant result was found in Auspitz sign.

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

Data reveals that group A and group B showed statistically insignificant difference in appearance of all sign of Ekakushtha except Kandu, group A shows better result in Kandu than group B. In group A and group B, 73.33% and 20% of the patients showed moderate improvement while mild improvement were seen in 20% and 60% of patients respectively. There is 6.66% patients showed marked improvement in group Abut there is no patient showed marked improvement in group B. Unchanged result was found in 20% patients in group B. There is none patient was observed for complete remission in group A and B.

Clinical study was carried out after permission from institutional ethics committee clearance (GAV/VAD/IEC/60/2020, Dated 20/08/2020) and retrospectively registered at Clinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2021/04/032979 [Registered on 20 / 04 /2021]. Study type was interventional, open label randomized clinical trial. It explores with description of the aims and objectives, materials and methods, criteria of selection of the patients, general observations and effect of therapy. Also a detailed description about the diagnostic criteria for psoriasis along with the subjective and objective criteria for the assessment of results is stated here. Specialized scoring pattern for criteria for assessment was adopted were assessed in terms of percentage relief and statistical evaluation. Thereafter the observations and results are presented in tabular form followed by interpretation. The overall assessment of therapy was decided on the basis of scoring pattern. In this study, total 35 patients were selected and randomly divided into two groups, 16 in group A and 19 in group B respectively. Total 30 patients i.e. 15 in group A and 15 in group B completed the treatment with JY and JM respectively. Duration of treatment was 4 weeks along with follow up of 1 week. The observations were made on the parameters 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, haematocrit values were recorded before and after treatment by adopting scoring pattern.

Maximum numbers of patients (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 as etiological factor. Ahara dominant in Guru (82.86%) and Sheeta Guna (54.28%) was dominant majority of enrolled. consumption of Viruddha Ahara (60%) followed by Pishtanna (57.14%) was found maximum.

Maximum patients developed the disease less than a year (68.57%) and a negative family history of psoriasis 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 highly significant result was found` in Matsyashakalopama, Krishna-Aruna Varna and Kandu, while significant result was found in Rukshata. In group B highly significant result was found in Kandu, while significant result was found in Matsyashakalopama, Krishna-Aruna Varna, Rukshata, Nidranasha,. Group A was seen to provide better results on complaints Kandu (86.67%), Matsyashakalopama (73.33%), Rukshata (43.33%) and Krishna-Aruna Varna (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 group highly significant result was found in PASI and DLQI score, while in both group significant result was found in Auspitz sign.

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

Data reveals that group A and group B showed statistically insignificant difference in appearance of all sign of Ekakushtha except Kandu, group A shows better result in Kandu than group B. In group A and group B, 73.33% and 20% of the patients showed moderate improvement while mild improvement were seen in 20% and 60% of patients respectively. There is 6.66% patients showed marked improvement in group Abut there is no patient showed marked improvement in group B. Unchanged result was found in 20% patients in group B. There is none patient was observed for complete remission in group A and B.

Clinical study was carried out after permission from institutional ethics committee clearance (GAV/VAD/IEC/60/2020, Dated 20/08/2020) and retrospectively registered at Clinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2021/04/032979 [Registered on 20 / 04 /2021]. Study type was interventional, open label randomized clinical trial. It explores with description of the aims and objectives, materials and methods, criteria of selection of the patients, general observations and effect of therapy. Also a detailed description about the diagnostic criteria for psoriasis along with the subjective and objective criteria for the assessment of results is stated here. Specialized scoring pattern for criteria for assessment was adopted were assessed in terms of percentage relief and statistical evaluation. Thereafter the observations and results are presented in tabular form followed by interpretation. The overall assessment of therapy was decided on the basis of scoring pattern. In this study, total 35 patients were selected and randomly divided into two groups, 16 in group A and 19 in group B respectively. Total 30 patients i.e. 15 in group A and 15 in group B completed the treatment with JY and JM respectively. Duration of treatment was 4 weeks along with follow up of 1 week. The observations were made on the parameters 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, haematocrit values were recorded before and after treatment by adopting scoring pattern.

Maximum numbers of patients (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 as etiological factor. Ahara dominant in Guru (82.86%) and Sheeta Guna (54.28%) was dominant majority of enrolled. consumption of Viruddha Ahara (60%) followed by Pishtanna (57.14%) was found maximum.

Maximum patients developed the disease less than a year (68.57%) and a negative family history of psoriasis 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 highly significant result was found` in Matsyashakalopama, Krishna-Aruna Varna and Kandu, while significant result was found in Rukshata. In group B highly significant result was found in Kandu, while significant result was found in Matsyashakalopama, Krishna-Aruna Varna, Rukshata, Nidranasha,. Group A was seen to provide better results on complaints Kandu (86.67%), Matsyashakalopama (73.33%), Rukshata (43.33%) and Krishna-Aruna Varna (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 group highly significant result was found in PASI and DLQI score, while in both group significant result was found in Auspitz sign.

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

Data reveals that group A and group B showed statistically insignificant difference in appearance of all sign of Ekakushtha except Kandu, group A shows better result in Kandu than group B. In group A and group B, 73.33% and 20% of the patients showed moderate improvement while mild improvement were seen in 20% and 60% of patients respectively. There is 6.66% patients showed marked improvement in group Abut there is no patient showed marked improvement in group B. Unchanged result was found in 20% patients in group B. There is none patient was observed for complete remission in group A and B.


 
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