| CTRI Number |
CTRI/2025/02/081086 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study The Efficacy Of Shatavari Ghrita In Vatarakta (Gout) With Investigation Of Serum Uric Acid |
|
Scientific Title of Study
|
Single Arm Clinical Study To Evaluate The Efficacy Of Shatavari Ghrita In Vatarakta (Gout) With Special Reference To Serum Uric Acid |
| 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 Mahesh Hiralal Ghumare |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur, Department of Rognidan, Division No 1, Room no 1 tal Walwa Dist Sangli Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888522725 |
| Fax |
|
| Email |
maheshghumare98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gouri Mohite |
| Designation |
Professor And HOD |
| Affiliation |
LRP Ayurvedic Medical College And Hospital |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur, Department of Rognidan, Division No 1, Room no 1 tal Walwa Dist Sangli Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA
415409
India |
| Phone |
8806073556 |
| Fax |
|
| Email |
gaurimohite492@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gouri Mohite |
| Designation |
Professor And HOD |
| Affiliation |
LRP Ayurvedic Medical College And Hospital |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur, Department of Rognidan, Division No 1, Room no 1 tal Walwa Dist Sangli Sangli MAHARASHTRA 415409 India
MAHARASHTRA
415409
India |
| Phone |
8806073556 |
| Fax |
|
| Email |
gaurimohite492@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College and Hospital and Research Centre, Islampur. taluka Walwa Dist Sangli State Maharashtra Country India Pincode 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Mahesh Hiralal Ghumare |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangli |
| 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 Mahesh Hiralal Ghumare |
LRP Ayurvedic Medical College And Hospital |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur, Department of Rognidan, Division No 1, Room no 1 tal Walwa Dist Sangli Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA |
8888522725
maheshghumare98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Loknete Rajarambapu Patil Ayurved Mahavidyalay Sangli Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M206||Acquired deformities of toe(s), unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavari Ghrita, Reference: Bhaishajya Ratnavali Adhyaya no 27 shloka no 130, Route: Oral, Dosage Form: Ghrita, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Age group 18 to 60 yrs.
2)Patients having sign and symptoms such as Sandhishoola,Sprashasahatva,Sandhishotha, Stabdhata,Daha
3)Patient of either gender, irrespective of socioeconomic status |
|
| ExclusionCriteria |
| Details |
1)patient below 18 years and above 60 years old.
2)Pregnant women and lactating mother.
3)known case of HIV
4)know case of HBSAG
5)Disorders like Rheumatoid arthritis, Tubercular arthritis Syphilitic arthritis, Maleria , Neurological disorder
know case of chikungunya
Systemic lupus erythematos |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Shatavari Ghrita in the management of Vatarakta [Gout] with special reference to Serum Uric Acid? |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study vatarakta in detail according Ayurved
2)To study gout in detail according to modern science
3)To study Shatavari Ghrita properties
4)To study Serum Uric acid in details.
5)To study effect of shatavari ghrita on sign and symptoms of Vatarakta and on serum uric acid level |
30 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/02/2025 |
| 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="0"
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
Modification(s)
|
In Vatarakta, both Vata and Rakta gets vitiated by exposed of their respective Nidana. The dushit Rakta Dhatu obstruct the passage of Vata dosha. Due to obstruction Vata dosha cause worsening of vikruti of Vata dosha. Continuing the pathology the severely vitiated Vata dosha also further disturbs the dusta Rakta Dhatu. This is known as Vatarakta.Vatarakta is a disorder of Vata Dosha which is associated with Dushya Rakta, the chief complaint of patients is joint pain with onset from Hasta, Padangushtamulagata sandhi & then it migrates to other joints in a way similar to ’Akhuvisha’s. (Rat Poison). The disease which is most commonly seen in kudhavata i.e. near the ankle or in smaller joints. The classical symptoms include Shvayathu, Bheda, Toda, Shoola, Sparshasahatva
Considering, the clinical presentation and textual references of the disease it can be correlated with ’Gout’ explained in modern medicine.
Gout is the most common type of inflammatory arthritis and is associated with impaired quality of life. The formation and deposition of monosodium urate crystals takes place in and around joints as serum uric acid levels rise and the physiological saturation threshold for uric acid is exceeded in the body fluids. Clinical manifestations of mono sodium urate crystal deposition include acute attacks of severe pain and inflammation affecting peri-pheral joints, most commonly the first metatarso- phalangeal joint
Shatavari Ghrita was mentioned in Bhaishajya Ratnawali in the management of Vatarakta disease. It includes Shatavari, Goghrita and Godugdha. Shatavari has Madhura, Tikta Rasa, Guru, Snigdha Guna, Madhura Vipaka and Sheeta Virya. It acts on Vata and Pitta Dosha. Shatavari helps in reducing burning sensation, due to having Sheeta Virya, and Madhur Vipaki. It reduces pain due to guru, singdha guna and madhur vipaki. These all properties help in reducing Vata and Rakta vitiation. Shatavari acts as vataghna and raktadushtihar. Shatavari has pharmacological actions like Antioxidant; Anti-Inflammatory and Immunomodulation.
The determination of uric acid in serum is most commonly performed for the diagnosis of gout Increased uric acid levels are also found in leukemia, polycythemia and conditions associated with decreased renal function.
Uric Acid is a normal waste product that body makes when it Breaks down chemicals called Purines.
If uric acid builds up in in the blood it can Form needle shaped Crystals in around Joint This Condition is called Gout. |