| CTRI Number |
CTRI/2024/11/077404 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study Of Navakarshik Kwath And Navakarshik Ghanvati in The Management Of Gout. |
|
Scientific Title of Study
|
A Clinico-Comparative Study Of Navakarshik Kwath And Navakarshik Ghanvati in The Management Of Vatarakta W.S.R. to Gout |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalik Ram Verma |
| Designation |
PG Scholar |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh |
| Address |
Kayachikitsa Department, Shri Narayan Prasad Awasthi Government Ayurved College & Hospital Raipur Chhattisgarh
OPD no. 2 & 18
Raipur CHHATTISGARH 492010 India |
| Phone |
9827898685 |
| Fax |
|
| Email |
shalikverma1980@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pramod Kumar Baghel |
| Designation |
Assistant Professor |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh |
| Address |
Kayachikitsa Department, Shri Narayan Prasad Awasthi Government Ayurved College & Hospital Raipur Chhattisgarh
OPD no. 2 & 18
Raipur CHHATTISGARH 492010 India |
| Phone |
7354450821 |
| Fax |
|
| Email |
dr.pkbaghel08@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shalik Ram Verma |
| Designation |
PG Scholar |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh |
| Address |
Kayachikitsa Department, Shri Narayan Prasad Awasthi Government Ayurved College & Hospital Raipur Chhattisgarh
OPD no. 2 & 18
CHHATTISGARH 492010 India |
| Phone |
9827898685 |
| Fax |
|
| Email |
shalikverma1980@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kayachikitsa Department Shri Khudadad Dungaji Government Ayurved Hospital Raipur Chhattisgarh
OPD no 2 and 18 |
|
|
Primary Sponsor
|
| Name |
Office of Principal Shri NPA Government Ayurveda College Raipur Chhattisgarh |
| Address |
Kayachikitsa Department
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shalik Ram Verma |
Shri Khudadad Dungaji Ayurveda Hospital Raipur Chhattisgarh |
OPD No 2 and 18 Male and Female IPD of Kayachikitsa Department Shri Khudadad Dungaji Ayurveda Hospital Raipur Chhattisgarh Raipur CHHATTISGARH |
9827898685
shalikverma1980@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Principal Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Navakarshik kwath, Reference: Vangasen samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Navakarshik Ghanvati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Vatarakta Patients Based on Symptoms Described in Ayurveda Samhita and Modern Textbook |
|
| ExclusionCriteria |
| Details |
Chronic Disease Conditions like Diabetes, Renal Failure
Antenatal Care
Septic in Joints
Skin Sensitivity
Who Disagree with the Trial |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Observe the Effect of Navakarshik Kwath and Navakarshik Ghanvati in the Management of Vatarakta W.S.R. to Gout |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study any Adverse Effect of Navakarshik Kwath and Navakarshik Ghanvati in the Management of Vatarakta W.S.R. to Gout |
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 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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 Yet Recruiting |
| 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
|
INTRODUCTION
-
In
Ayurveda Samhita texts, we find a detailed classification of disease in which
80 types of Vataj diseases, 40 types of Pittaj and 20 types of Kaphaj disease
are classified. Although it is not possible to name all the disease, yet treatment
shoild be done after studying the Dosha and diagnosis.
Origin
of Vatavyadhi -
There
are two main reason for Vata Prakop - 1. Dhatukshaya janya 2.
Marga awarodh janya
The
origin of Vatarakta said to be due to Rheumatism in the joint due to Dhatukshaya
and Margawarodh of Rakta due to Avaran of Vayu .
Nidan
of Vatarakta -
Generally,
men with delicate nature (Sukumar Vyakti) and Mithya ahar vihar, living habit
and those who are prone to grief, and those who indulge in sexual intercourse,
drinking alcohol and excessive exercise, those who have food and living
contrary to the season and harmony, and those who use wrong kind of affection
and those who are obese, affected by Gout.
Need
of the Study – Gout is a metabolic disorder that
occurs in middle age and small joint. That is due to reasons that contaminate
the blood and by consuming food and lifestyle that increases vata, the air
passage is blocked by vayu and contaminated blood. The disorder that arises in
such a condition should be considered as vatrakta or vata shonit.
According
to modern opinion, gout is a disease that occurs as a result of abnormal
metabolism of protein in which crystal of uric acid (Monosodium urate Monohydrate)
are produced in our body. Due to which the level of uric acid in the blood
becomes higher than normal. This disease is usually found more in men.
According
to a research 0.58 to 2.89 % of the world’s total population is found to be
affected by Gout. In Asian countries the prevalence of Gout is about 25.8per
1000 people and level of uric acid is found to be higher than normal.
In
modern medical science, the side effects of the medicines used for the
treatment of gout are seen, which mainly include skin deformity, convulsion and
excessive thirst. Due to the use of these medicines, symptoms of loss of
strength are especially reflected in the patients.
Hence
the use of Ayurvedic medicines for easy, accessible and safe treatment of gout
cannot be denied, however there is a need for extensive research in gout
disease.
Hence
for my dissertation, I have chosen the subject of experimental study of
Navakarshik kwath described in vangasen samhita for the treatment of gout. In
which, according to the drug concept and
methods of intake, I have chosen the subject of comparative medical study of
the kwath and ghanvati form of the used drug. So that gout patients can be
treated effectively and safely.
Type of study- Prospective,
Interventional, Open level, Single arm, Non-Randomized, Comparative clinical study |