CTRI Number |
CTRI/2025/06/089594 [Registered on: 26/06/2025] Trial Registered Prospectively |
Last Modified On: |
25/06/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of two ayurvedic treatments for gout with herbal purgation and medicated enema therapy |
Scientific Title of Study
|
Randomized comparative clinical study to evaluate efficacy of virechan karma using Kashmaryadi kashay and Ardhamatrik niruh basti in vaatrakta with special reference 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 |
Shubhada Santosh Kulkarni |
Designation |
PG scholar |
Affiliation |
Arogyashala Rugnalaya Ganeshwadi Nashik |
Address |
OPD NO 20 Arogyashala Rugnalaya Ganeshwadi Nashik
Nashik MAHARASHTRA 422003 India |
Phone |
7410139493 |
Fax |
|
Email |
kulkarnishubhada123@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr.Savita Kulkarni |
Designation |
Guide and HOD |
Affiliation |
Arogyashala Rugnalaya Ganeshwadi Nashik |
Address |
OPD NO 20 Arogyashala Rugnalaya Ganeshwadi Nashik
Nashik MAHARASHTRA 422003 India |
Phone |
9423081487 |
Fax |
|
Email |
drsavita.k07@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Shubhada Santosh Kulkarni |
Designation |
PG scholar |
Affiliation |
Arogyashala Rugnalaya Ganeshwadi Nashik |
Address |
OPD NO 20 Arogyashala Rugnalaya Ganeshwadi Nashik
Nashik MAHARASHTRA 422003 India |
Phone |
7410139493 |
Fax |
|
Email |
kulkarnishubhada123@gmail.com |
|
Source of Monetary or Material Support
|
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik 422003 |
|
Primary Sponsor
|
Name |
Dr Shubhada Santosh Kulkarni |
Address |
OPD NO 20 Arogyashala Rugnalaya Ganeshwadi Nashik 422003 Maharashtra |
Type of Sponsor |
Other [Self] |
|
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 Shubhada Santosh Kulkarni |
Arogyashala Rugnalaya |
OPD NO 20 Panchakarma OPD Nashik MAHARASHTRA |
7410139493
kulkarnishubhada123@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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M258||Other specified joint disorders. Ayurveda Condition: VATARAKTAM, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Procedure | - | bastikarma | (Procedure Reference: chakradatta, Procedure details: basti once a day) (1) Medicine Name: dashamula kwath, Reference: chakradatta, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 7 Days | 2 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: charak chikitsasthan 29, Procedure details: After snehapana & samyak snugdh lakshan kashmaryadi kashay will be given to the patient and kept under supervision for 24 hours) (1) Medicine Name: kashmaryadi kashay, Reference: charak chikitsasthan 29, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 1 Days |
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Diagnosed patients of Vataraktawith symptom such asSandhishula,Sandhidaha, Sparshasahatva,Sandhishoth, Sandhivaivarnya.
Patient with raised Serum Uric Acid Level (more than 7.0 in Male and more than 6.0 in Female)
Patients between age group 20 -70 years of either sex.
Patient willing for trial and giving written cosent.
Patient with all socio-economic status.
virechan arha and basti arha |
|
ExclusionCriteria |
Details |
Below 20yrs. and above 70 years old patients With Known case of major systemic disorder such as IHD, MI, Uncontrolled DM, Uncontrolled Hypertension, CKD
Patients other than Gouty Arthritis
Virechan anarha and basti anarha
Patient not willing for trial.
Pregnant and lactating mother
|
|
Method of Generating Random Sequence
|
|
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
decrease in serum uric acid level |
7 days
|
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the effect of Kashmaryadi kashay as virechan kalpa & ardhamatrik niruh basti as pain reliever in Vatarakta using VAS Scale.
To study the effect of Kashmaryadi kashay as virechan kalpa in decreasing Serum Uric Acid Level in Vatarakta using Serum Uric Acid test. |
7 days |
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
09/07/2025 |
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="0" Months="3" 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
|
Vatarakta is a great medical problem throughout the world. It is a great enemy in the society, because it distresses the human life. In Ayurvedic context, various treatment modalities have been suggested to get rid of this disease. In Vatarakta, both Vata and Rakta get aggravated and vitiated by their hetus and ultimately vayu gets obstructed by vitiated Rakta. The classical texts lay down ample importance to the functions and characteristics of vata. At the same time, rakta being the foremost body tissue also plays an important role in sustaining the healthy life style of a person. Vatarakta is a disease where both VataandRakta are afflicted by distinct etiological factors. The disease characterized by the abnormality of raktadhatu due to morbidity of vatadosha is called as Vatarakta. “Vatadushitamraktam yatra rogavisheshah” Vata dosha becomes enraged by frequent use of Kashaya(astringent), katu (pungent), Tikta (bitter), Alpahara(scanty diet), RukshaAhara(dry food articles), Abhojana(abstinence of food) or by regular riding on Ashva(horse), Ushtra(camel) or Yana(vehicle) etc;this agitated Vataenters into blood through carrying channels of the body and gets obstructed in its passage by vitiated Rakta Dhatu, thus affecting the entire blood and leading to Vatarakta. Once again Acharya Charaka described that Vata due to its Sukshmatva (subtleness), Sarvasaratva (pervasiveness) properties and Rakta due to its Dravatva(liquidity), Saratva (flowing nature) properties; circulate through the body and blood vessels (RaktavahaSrotasa) and get obstructed in Sandhi(joints). Due to torsion nature of its course in joints;Rakta and Vata again get agitated. After localization and in combination with Pitta Dosha they cause different types of Shula (pain) according to predominance of Doshas. Vatarakta is an age old common condition prevalent all over the world. On the basis of symptomatology and chronicity of disease, this can be correlated with a similar condition of modern medicine named as Gout.Gout is a clinical syndrome and is a group of metabolic diseases in which clinical manifestation is associated with tissue deposition of crystals of monosodium urate monohydrate from Hyperuricemia body fluids. Incidence of Gout appears to have increased over in a few decades due to increasing industrialization,urbanization,faultydietary habits,radiation, drug toxicity and other factors responsible directly or indirectly for the disease Gout. Hyperuricemia and Gout may result from increased urate production or decreased uric acid excretion or both. Reported prevalence of Gouty Arthritis is 2.0 to 2.6 per 1000 patients, usually between the age group of 25-50 years. Sushruta explained Vatarakta entity in ‘Mahavatavyadhichikitsa’. Hence it is an identical one among all other vatavyadhyi. It is also known as vatashonita, khhuddavata, vatabalas, and aadhyavata. Panchakarma is treatment modality used very extensively and effectively in Ayurveda. It plays an important role in Vatarakta. Acharya Charaka elaborate virechan as Shodhan karma in vaatrakta specifically in pittaj and raktaj type. A medicine which is clinically viable, cost effective, easy to administer, gives early recovery and minimize the discomfort to the patient is in high demand. Kashmaryadi kashayas virechan kalpa is one of the preparations especially mentioned by charak. Acharya Charak has clearly mentioned the relevance of Kashmaryadi kashay as virechan kalpa in VataraktaChikitsa. So in the present study Kashmaryadi kashay as virechan has been selected.With this, NidanaParivarajana and PathyaApathya will be advised to the patients.Out of which I have selected Kashmaryadi kashay as virechan in one group and Ardhamatrik niruh basti in another group for given duration in Vataraktavya. |