| CTRI Number |
CTRI/2022/02/040703 [Registered on: 28/02/2022] Trial Registered Prospectively |
| Last Modified On: |
19/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Clinical Study of Vidangadi Pindi and Khadirastaka Kwatha Siddha Tailam in The Psoriasis. |
|
Scientific Title of Study
|
CLINICAL STUDY OF VIDANGADI PINDI AND KHADIRASHTAKA KWATH SIDDHA TAILAM IN THE MANAGEMENT OF EKKUSHTHA W.S.R.TO PSORIASIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dinesh Sahu |
| Designation |
Pg Scholar in Department of Kayachikitsa |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur |
| Address |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur
Raipur
CHHATTISGARH
492010
India |
| Phone |
7694963211 |
| Fax |
|
| Email |
sahudinesh711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Diwan |
| Designation |
Lecturer in Department of Kayachikitsa |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur |
| Address |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur
Raipur
CHHATTISGARH
492010
India |
| Phone |
9770933579 |
| Fax |
|
| Email |
rashmi.diwan3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeevan Lal Sahu |
| Designation |
Lecturer in Department of Kayachikitsa |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur |
| Address |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur
Raipur
CHHATTISGARH
492010
India |
| Phone |
8824099797 |
| Fax |
|
| Email |
jeev.dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF KAYACHIKITSA
SHRI NARAYAN PRASAD AWASTHI GOVT. AYURVED COLLEGE RAIPUR CG
|
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa Shree Narayan Prasad Awasthi Ayurved College Raipur |
| Address |
Shree Narayan Prasad Awasthi Government Ayurved College Raipur |
| Type of Sponsor |
Other [Government Ayurved College Raipur] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shree Narayan Prasad Awasthi Ayurved College Raipur |
Shree Narayan Prasad Awasthi Ayurved College Raipur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dinesh Sahu |
OPD NO.2 and 18 IPD Department of Kayachikitsa |
Shree Narayan Prasad Awasthi Government Ayurved College Raipur
Raipur
CHHATTISGARH |
7694963211
sahudinesh711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERMENT AYURVEDA COLLEGE RAIPUR (C.G.) 492010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidangadi Pindi , Reference: (Astang Hridyam Chikitsa Chapter 19/45, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Aaragwadhphalamajja Kwath), Additional Information: Khadirastaka Kwath Siddha Tail For Local Application In Both Group
Anupan Use In One Group | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Khadirashtaka Kwath Siddha Taila, Reference: Yogaratnakar Kushtha Chikitsa 2, Route: Topical, Dosage Form: Taila, Dose: 00(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
based on clinical symptoms mentioned in classical text book of ayurveda and modern |
|
| ExclusionCriteria |
| Details |
below 18 year and more than 60 year
patient with other systemic disorder like chronic cardiac illness tuberculosis, cancer, AIDS and other endocrine disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduce the symptoms of psoriasis |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improve the Quality of Life |
90 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)
|
01/04/2022 |
| 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)?
Response - NO
|
|
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. |