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CTRI Number  CTRI/2024/12/078012 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 07/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Clinical Study of Chandrashakaladi Vatak and Navak Kashaya Siddha Taila in Ekakushtha W S R to Psoriasis 
Scientific Title of Study   A Comparative Clinical Study to Evaluate The Efficacy of Chandrashakaladi Vatak and Navak Kashaya Siddha Taila in The Management of Ekakushtha W S R to Psoriasis 
Trial Acronym  Interventional 
Secondary IDs if Any  
Secondary ID  Identifier 
RITIK KUMAR TIWARI  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ritik Kumar Tiwari 
Designation  Pg Scholar Department of Kayachikitsa 
Affiliation  Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh  
Address  Opd No 2 And 18,Department of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9340409477  
Fax    
Email  ritik942424@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rashmi Diwan 
Designation  Lecturer in Department of Kayachikitsa 
Affiliation  Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh  
Address  Opd No 2 And 18,Department Of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9770933579  
Fax    
Email  rashmi.diwan3@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aruna Ojha 
Designation  Proffesor in Department of Kayachikitsa 
Affiliation  Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 
Address  Department of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9424401858  
Fax    
Email  arunaojha90@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010 
 
Primary Sponsor  
Name  Department of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur  
Address  Department of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010 
Type of Sponsor  Other [Goverment Ayurved College Raipur Chhattisgarh 492010] 
 
Details of Secondary Sponsor  
Name  Address 
Department of kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh  Department of kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ritik Kumar Tiwari  Department of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur   Opd No 2 And 18,Department of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh
Raipur
CHHATTISGARH 
9340409477

ritik942424@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Goverment Ayurved College Raipur Chhattisgarh 492010  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Chandrashakaladi vatak, Reference: ashtang hridaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: jala), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: chandrashakaladi vatak, Reference: ashtang hridaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: jala), Additional Information: along with navak kashaya siddha taila local application
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Symptoms According to Ayurvedic and Modern Textbook
Anhydrosis
Extents of Lesion
Scaling
Deep Black Raddish Discoloration
Dryness of Skin
Itching
Secretion
Burning Sensation
 
 
ExclusionCriteria 
Details  Less Than 18 Years and More Than 80 Years
Lactaing Mother and Pregnant Lady
Leprosy
Chronic Cardiac illness
Chronic Tuberculosis
Endocrine Disorder
Severe Hypertension
Bleeding Disorder
Dm Type1 and Type 2
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduce the Symptoms of Ekakustha especially Scaling,Dryness of Skin,Extent of Lesion,Itching,Secretion,Auspitz Sign,Candle Grease Sign  Reduce the Symptoms of Ekakustha especially Scaling,Dryness of Skin,Extent of Lesion,Itching,Secretion,Auspitz Sign,Candle Grease Sign 
 
Secondary Outcome  
Outcome  TimePoints 
Improve the quality of life  60 Days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

All the Acharyas have described the five sense organs (auditory sense, skin sense, eye sense, taste sense, smell sense), in which skin is the largest and most important sense . The skin is the mirror that reflects the harmony of the internal functions of the body. Any change in skin color troubles the patient mentally and physically.

In Ayurvedic texts, all types of skin disorders have been included under kustha. Acharyas have described the skin under the sense of touch among the five senses. Along with creating a protective cover over the entire body, it also performs functions like emission of sweat from the body, regulation of water content, regulation of body temperature, emission of shade and color etc. Therefore, it is very important for the skin to be healthy and clean. There are descriptions of 18 types of kustha of which 7 are mahakustha and 11 are kshudrakustha.  Among these kshudrakustha, there is a description of Ekakushtha, which Acharya Charak has mainly considered as Vatakfaj and Sushruta has considered it as Kafaj. In which the complexion of the body becomes somewhat black or red, it is a disease called ekakustha. That ekakustha in which there is no sweating, which covers a large area and whose skin is like a fish, is called ekakustha.  

Symptoms of ekakustha include the appearance of black-coloured, oozing, painful rashes on the skin, which look like fish scales and are sweat-less. On the basis of symptoms, it can be reconciled with psoriasis described in modern texts. The reason for its origin is unknown. This is accepted as autoimmune disease in modern opinion.

 Skin disease is the most common problem among all types of health problems. According to a research, 900 million people are affected by it all the time. And according to the World Psoriasis Day Association, 125 million people worldwide suffer from psoriasis, 2 to 3 percent of the total population.

 Skin is an important part of the external appearance of humans, any deformity in which causes physical as well as mental depression in the person and has a negative impact on the quality of life. 

 The prevalence of psoriasis in India is 0.44-2.8 percent, the main reason for which is not proper adherence to routine, menstrual cycle, diet, Tridosha present in equilibrium gets agravated and causes diseases by contaminating Agni . 

 Lack of sweating in the skin and symptoms similar to fish scales are visible and the daily life of the patient gets affected.

 In the present era, skin disorders are found very widely, according to the theory of skin diseases, out of all the diseases, the number of patients suffering from skin diseases is about 10-15%.

A completely successful treatment of leprosy is required, hence this topic has been selected in an effort to provide its successful, simple and effective treatment.

 Ekakustha is a vatakaphaj and blood disorder. 

 Most of the constituent substances of Chandrashakaladi Vatak are vatakapha shamak and ushna virya. Among the juices, bitter and pungent juices predominate. Therefore, due to bitter juice and ushna virya, it is digestive, fire-enhancing and clay-absorbent. Since ekakustha is of Vatakfaj and Raktaj nature, this medicine can prove helpful in its eradication.

 Most of the substances in Navak Kashaya Siddha oil are kaphapitta samak and ushanavirya,

Among the juices, bitter, pungent and astringent juices predominate. Therefore, due to bitter juice and ushna virya, it will work as a rasayan  and anti itching  karma. External use of oil will help in reducing dryness and itching in ekakustha and in improving complexion. Due to its anti itching properties, this medicine can be effective in the selected disease.

 For the present study, on ekakustha as shaman therapy, the medicine I choose is a suitable natural product that will make it possible for patients to live a high quality of life along with reducing the specific symptoms of Anhydrosis,Extents of lesion,Scaling,Deep Black Raddish discoloration,Dryness of skin,Itching,Secretion ,Burning sensation.

These medicines have properties of kapha samak, aampachak, agnideepak, rasayan and kandughna without any side effects in our texts. Considering the magnitude of ekakustha, I am doing a comparative clinical study of chandrashakladi vatak & navak Kashaya siddha taila in the management of ekakustha

the volunteers will be informed about the study protocol. willing participants will be randomly selected . clinical research format will be prepared and validated before the study approval will be taken from the IEC of the NPA government Ayurved college and hospital, Raipur C.G. and CTRI registration will be done. after selection, each participant will be tasted individually and selected according to the selection criteria.

Forty patients of ekakustha will be selected from Kayachikitsa OPD and IPD Shri NPA government Ayurved college and hospital, Raipur C.G. The case selection was in regards to age, sex, occupation, and socioeconomic conditions. Both acute and chronic phases of ekakustha

 The present study is a prospective, interventional, single-arm, open-labeled non-randomized clinical study. A total of 40 clinically diagnosed and registered patients of ekakustha  were divided randomly by coin method into two groups. Each group will have 20 patients.

 Group A: 20 clinically diagnosed patients of ekakustha will be treated with chandrashakladi vatak

two tablets(each 500 mg) three times in a day before meal with water and for external application navak Kashaya siddha taila for 60 days.

Group B: 20 clinically diagnosed patients of ekakustha were treated with chandrashakladi vatak two tablets(each 500 mg) three times in a day before meal with water

Ingredient of chandrashakladi vatak :- bakuchi,chitrak,haldi,vayavidanga,tuvrak,suddha bhallatak, haritki, vibhitki,aamalki

Ingredient of navak Kashaya siddha taila :- haritki , vibhitki, aamlaki,nimba, patol,manjistha, kutki, vacha, haldi


 
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