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CTRI Number  CTRI/2020/03/024090 [Registered on: 19/03/2020] Trial Registered Prospectively
Last Modified On: 19/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Aragvadhadi gana ghanvati (tablet) and panchkarma (mainly virechan karma) in skin disorder patients (Psoriasis) 
Scientific Title of Study   A clinical study of Aragvadhadi gana ghanvati and virechan karma in the management of Ekakushtha w.s.r. Psoriasis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srishti Chandrakar 
Designation  MD Scholar 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh

Raipur
CHHATTISGARH
492010
India 
Phone  8109694056  
Fax    
Email  srishtichandrakar03@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jeevan Lal Sahu 
Designation  Lecturer 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh

Raipur
CHHATTISGARH
492010
India 
Phone  8824099797  
Fax    
Email  jeev.dr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Srishti Chandrakar 
Designation  MD Scholar 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh

Raipur
CHHATTISGARH
492010
India 
Phone  8109694056  
Fax    
Email  srishtichandrakar03@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 
 
Primary Sponsor  
Name  Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt Ayurved College Raipur CG 
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 
Type of Sponsor  Other [Government Ayurved College Raipur Chhattisgarh] 
 
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 Srishti Chandrakar  Shri Khudadad Doongaji Government Ayurved Hospital Raipur CG  OPD No 2 and 18 IPD Department of Kayachikitsa Shri Khudadad Doongaji Government Ayurved Hospital Raipur Chhattisgarh
Raipur
CHHATTISGARH 
8109694056

srishtichandrakar03@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: L409||Psoriasis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Aragvadhadi Gana for internal use and Taila for local application and virechan Karma  Dose: 1-2 gm will administered with Lukewarm water Orally for 90 days Folloup:30 days 
Intervention  Aragvadhadi Gana Ghanvati for internal use and Taila for local application  Dose: 1-2 gm will administered with Lukewarm water Orally for 90 days Folloup:30 days 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of age group between16 years to 60 years.
2.Sex- Male and Female both.
3.Symptoms mentioned in Ayurved and modern Texts
 
 
ExclusionCriteria 
Details  1.Patients of age group below 16 years and above 60 years.
2.Pregnancy.
3.Duration of disease- more than 10 years.
4.Patients who loses their immunity power.
5.Patients of Kushtha.
6.Patients with other systemic disorders like chronic cardiac illness, tuberculosis, endocrine disorders, severe hypertension, bleeding diathesis.
7.Cancer, hepatitis, HIV.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of Aragvadhadi gana ghanvati and virechan karma in the management of Psoriasis  90 days or 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
As There Is Physically And Mentally Health Satisfaction So It Improves the Quality of Life  90 days or 3 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2 
Date of First Enrollment (India)   23/03/2020 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Ayurved is an ancient medical science. It is not only medical system but also it includes life philosophy in which there is description of seasonal regimen such as Dincharya, Ratricharya and Ritucharya. A person who follows this seasonal regimen described in Ayurved Samhita’s is always healthy. Intake of Mithya Ahara Vihara causes suffering from various diseases. In Ayurved classics, there is complete description of how to regain health. Two main aims of Ayurved are to protect health of healthy person and to cure disease of diseased person (ch. su. 30/26).

Person is said to be healthy when Dosha, Dhatu (digestive fire), Dhatvagni is in proper state and Mana (mind), Atma (soul), Indriya (motor and sensory organs) are in pleasant state (su. Su. 15/48). Definition given by Acharya Sushrut is accepted by W.H.O. (world health organization).

According to W.H.O.

Health is a complete state of physical, mental, social and spiritual wellbeing not merely the absence of disease.

Now a day, disease related to skin is very common problem. According to Roxburgh book of common skin disease, about 10-15% of persons are suffering from dermatitis. Due to any type of skin deformity, person has to face physical, mental and social problems. Under dermatological disorders, Ek-kushtha (psoriasis) is commonly caused chronic skin disorder due to unknown reasons.

                            It is found in about 2% of people of the world. In Psoriasis, there is inflammation and disease spread at the rate of 10 times greater than that of normal skin. It affects people of all genders and castes. In this, there are Pidika (pimples) and Chakkate (Rashes) in the skin, which are clearly different from normal skin. Mostly it is found in head, upper back, lumbar region, arms, legs, especially in the outer surface of elbows and knees.

In Ayurved, all Twaka (dermatological) related disorders included under Kushtha. Due to various reasons, the natural color of the skin gets distorted due to leprosy. In case if proper treatment is not provided then entire body of the patient gets affected.

Skin also has special significance like other organs. It is the natural protective shield of the body which prevents various pathogenic causes like bacteria, viruses etc from entering the body. The first visible organ is skin and it covers whole extremities of the body.

BASIS OF TOPIC SELECTION

In the present era, dermal disorder is a serious problem. This disease affects a person not only physically but mentally as well. In terms of beauty skin is very important, but psoriasis is a skin disorder whose effects are seen in a person confidence and social activities. Psoriasis is one of the most common dermatologic diseases, affecting up to 1-2% of the world’s population. It occurs in all age groups and about equally in men and women. The main cause for the origin of disease is irregular eating habits, heavy diet etc.

BASIS OF MEDICINE SELECTION                   

1.    In Ayurveda, various formulations are described for the treatment of leprosy in which Sushrutokta Aragvadhadigana has been selected for the treatment of Psoriasis.

2.    Most of the constituent substances of this medicinal formulation having Bitter, astringent taste, Ushna Virya and Katu Vipaka which helps on balancing Kapha Dosha. Balancing Vata Dosha by having properties like Ushna Virya and Katu Vipaka. Therefore this medicinal formulation will be beneficial in the treatment of Psoriasis.

3.    In modern medical science, Psoriasis has been called as incurable.

4.    Steroid and immunosuppressive drugs are used for its treatment from which patient gets immediate benefit but after sometime the disease arises again. Using of these drugs doesn’t completely reduce the disease.

5.    All components of the selected drug substance are easily accessible.


 
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