| CTRI Number |
CTRI/2025/02/080722 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Effects of Vasadi Kwath and Amrutadi Kwath in Gout Treatment |
|
Scientific Title of Study
|
A RANDOMIZED CLINICAL STUDY TO COMPARE THE EFFICACY OF VASADI KWATH AND AMRUTADI KWATH 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 Gitanjali Shashikant Deshmukh |
| Designation |
MD Kayachikitsa Scholar (Ayurved) |
| Affiliation |
DR VJD Gramin Ayurved Mahavidyalay |
| Address |
OPD No 3, Department of Kayachikista, DR VJD Gramin Ayurved Mahavidyalay Near Renuka Mata Mandir,Tal Patur Dist Akola 444501 MAHARASHTRA INDIA
Near Renuka Mata Mandir,Tal Patur Dist Akola 444501 MAHARASHTRA INDIA
Akola
MAHARASHTRA
444501
India |
| Phone |
9168137283 |
| Fax |
|
| Email |
deshmukhgitanjali27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJayashree Katole |
| Designation |
Professor and Head Of The Department, Kayachikitsa |
| Affiliation |
DR VJD Gramin Ayurved Mahavidyalaya,Patur |
| Address |
OPD No 3 Department Of Kayachiktsa,DR VJD Gramin Ayurved Mahavidyalay Near Renuka mata mandir ,Patur,Tq. Patur Dist. Akola
Pin 444501
MAHARASHTRA
INDIA
Akola
MAHARASHTRA
444501
India |
| Phone |
9423847608 |
| Fax |
|
| Email |
drjrkatole@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJayashree Katole |
| Designation |
Professor and Head Of The Department, Kayachikitsa |
| Affiliation |
DR VJD Gramin Ayurved Mahavidyalaya,Patur |
| Address |
OPD No 3 Department Of Kayachiktsa,DR VJD Gramin Ayurved Mahavidyalay Near Renuka mata mandir ,Patur,Tq. Patur Dist. Akola
Pin 444501
MAHARASHTRA
INDIA
Akola
MAHARASHTRA
444501
India |
| Phone |
9423847608 |
| Fax |
|
| Email |
drjrkatole@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr VJD Gramin Ayurved Mahavidyalaya Tal patur,Dist Akola,state Maharashtra India Pin 444501 |
|
|
Primary Sponsor
|
| Name |
Dr. VJD Gramin Ayurved Mahavidyala |
| Address |
Dr. VJD Gramin Ayurved Mahavidyala,Near Renuka mata Mandir Tq Patur Dist Akola, MAHARASHTRA ,INDIA pin 444501 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gitanjali Shashikant Deshmukh |
Dr VJD Gramin Ayurved Mahavidyalaya,Patur, Tq Patur Dist Akola |
OPD No 3, Department Of Kayachiktsa,Dr VJD Gramin Ayurved Mahavidyalaya, Tal Patur Dist Akola State Maharashtra India Pin 444501
Akola
MAHARASHTRA |
9168137283
deshmukhgitanjali27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Dr. V.J. Dhone G.A.M. Patur Dist Akola |
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: Vasadi kwath , Reference: Bhaishajya ratnavali vatarkta chikitsa 27/22, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshna jal ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amrutadi kwath , Reference: Bhaishajya ratnavali vatarkta chikitsa 27/26, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshna jal ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients showing classical signs and symptoms of Vatarakta as described in Ayurvedic Samhita.
2.Unilateral first MTP joint attack.
3.Sr Uric acid level ranges between 7 to 12 mg/dl
4.Patients between the age of 20 to 60 years.
5.Patients from all socio-economic status.
6.Either gender.
|
|
| ExclusionCriteria |
| Details |
1.Patients not willing.
2.Patients with peptic ulcer.
3.Pregnant and lactating women.
4.Patients who have not been affected by NSAIDs.
5.Patients who have past history of malignant tumour.
6.Sr. Uric acid level below 7 mg/dl and above 12 mg/dl.
7.Patients with Sr. Creatinine level more than 2 mg/dl.
8.Patients below 20 years of age and above 60 yers of age.
9.Patients having any major chronic or acute systemic or surgical pathology.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Shool (Joints of hands and feet, Parva sandhi, etc.)
2)Stambha (Stiffness)
3)Daha (Burning Sensation)
4)Kandu (Itching)
5)Shoth (Swelling)
6)Twakkrushnata (Discoloration)
|
15Days, 30 Days, 45 Days after starting treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease symptoms completely |
18 Months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2025 |
| 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="6"
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
|
Vatarakta is chronic joint and body pain disease accompanied by pain, stiffness,
swelling over joints which involves vitiated Vata dosha as well as Rakta
dhatu.Aggrevated Vata is blocked
by vitiated Rakta which leads to
further aggrevation of Vata dosha.
The classical
symptoms of Vatarakta are Kandu, Shool, Stambha, Daha, Shoth,
Twakkrushnata. The etiological factors responsible for pathology and
clinical features of Gouty Arthritis are quite similar to the Vatarakta; hence Vatarakta can be correlated to Gout. Vatarakta manifest hands, feet fingers and all joints. Initially,
hands and feet are affected and later it spread to all over the body. Due to
subtleness and prevasiness of Vata and
liquidity and dispersibility of Rakta, it
circulates all over the body through blood vessels, get obstructed in the
joints which makes them further aggrevated and get logged there. The
changes of Vatarakta is expected to
increase in the upcoming years due to sedentary lifestyle, increasesd use of
computerization and also due to mental stress, excess travelling.
It is heterogenous
disorder that results in the deposition of Uric acid salt and crystals in and
around the joints. Its causes include over production of Uric acid seen in only
10-15% of subjects and in 80-90% Uric acid excretion is impaired.The incidence
of gout increases with increasing serum urate level.
It is a fact that
despite recent progress of modern science. It is unable to provide an effective
cure for Vatarakta except for giving
temporary relief through analgesics or continuous use of NSAIDs and steroids
for reliving pain lead to secondary complications lie kidney failure, liver
failure and gastritis.
The incidence of
gout increases with increasing serum urate level. The highest incidence of gout
occurs between 30 to 45 yrs in men and 55 -70 yrs in women. It is rare in
children and in premenopausal women partly due to mild uricosuric effect of
estrogenic hormone. The Maharashtra shows prevalence of gout is 2% . In modern treatment
no specific therapy is available. The aim is to control pain and maintain
maximal degree of joint mobility. The varieties of drug in the medical
management is NSAIDs/ Colchicine / Glucocorticoid which fail to modify course
of disease or unable to treat the disease and frequently meet with the ill
effects of these drugs.The main motto of study is to provide an Ayurvedic
treatment modality with minimal side effects as compared to modern treatment
In Ayurveda a detailed description of Vatarakta chikitsa is discussed in
all texts along with line of treatment, being Shodhana, Shaman and
Bahyachikitsa.
Many therapeutic modalities and different preparation arementioned by our ancient acharyas for Shamana, Shodhana and the
Bahyachikitsa, which can effectively treat the disease and it is the need of
hour to manage such a condition. Hence this topic is selected for study.
Keeping these facts in mind this
study has been under taken to bring out a treatment modality with no side
effects and long lasting life. In this study the role of Vasadi kwatha which is simple and potent kalpa described in Bhaishajya
Ratnavali with specified indication only in Vatarakta |