| CTRI Number |
CTRI/2025/05/086743 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Evaluation of Dhatryadi Kwatha in the Treatment of Vatarakta(Gout) |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Dhatryadi kwatha in the management of Vatarakta(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 Aakanksha Shriram Laghane |
| Designation |
Pg scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya |
| Address |
Opd no 13, kayachikitsa department,C.S.M.S.S Ayurved mahavidyalaya and rugnalaya,Kanchanwadi,Aurangabad431011 Aurangabad MAHARASHTRA 431011 India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9922218867 |
| Fax |
|
| Email |
aakankshalaghane18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrikant Gunwantrao Deshmukh |
| Designation |
Principal,Professor,H.O.D |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya |
| Address |
Opd no 13, kayachikitsa department,C.S.M.S.S Ayurved mahavidyalaya and rugnalaya,Kanchanwadi,Aurangabad431011 Aurangabad MAHARASHTRA 431011 India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9921553999 |
| Fax |
|
| Email |
dr.shrikantgdeshmukh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aakanksha Shriram Laghane |
| Designation |
Pg scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya |
| Address |
Opd no 13, kayachikitsa department,C.S.M.S.S Ayurved mahavidyalaya and rugnalaya,Kanchanwadi,Aurangabad431011 Aurangabad MAHARASHTRA 431011 India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9922218867 |
| Fax |
|
| Email |
aakankshalaghane18@gmail.com |
|
|
Source of Monetary or Material Support
|
| C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya ,Kanchanwadi,Aurangabad,Maharashtra,431011 |
|
|
Primary Sponsor
|
| Name |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya |
| Address |
Kanchanwadi,Aurangabad,Maharashtra,India 431011 |
| Type of Sponsor |
Private 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 Aakanksha Shriram Laghane |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya,Kanchanwadi |
Opd no 13, kayachikitsa department,C.S.M.S.S Ayurved mahavidyalaya and rugnalaya,Kanchanwadi,Aurangabad431011 Aurangabad MAHARASHTRA 431011 India
Aurangabad
MAHARASHTRA |
9922218867
aakankshalaghane18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Aurangabad |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kaishor guggul, Reference: Sharangdhar samhita madhyam khanda 7/70-81, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhatryadi kwatha, Reference: Vrundamadhav 23/13-14, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients irrespective of gender will be selected.
2 Patients of age group 30 years to 50 years will be selected.
3 Patient having clinical signs and symptoms of Vatarakta as described in Charak
chikitsa.
1. Sandhiruja (Pain)
2. Sparshasahatva(Tenderness)
3. Sandhidaha(Burning sensation)
4. Sandhishotha(Swelling)
5. Sandhistabdhata(Stiffness)
4 Patients showing signs and symptoms of Vatarakta less than 1 year.
5 Patient having Sr. uric acid level -
Above 7 mg/dl in male
above 6 mg/dl in female
|
|
| ExclusionCriteria |
| Details |
1. Patients below 30 years and above 50 years of age.
2. Patients with any known case of inflammatory joints disorders other than gout
– Rheumatoid arthritis, Tubercular arthritis, Osteoarthritis, SLE.
3. Patients with diagnosed cases of any systemic metabolic disorder viz.
Hypertension, Diabetes mellitus, Hypothyroidism, Hyperthyroidism.
4. Patients having Sr. uric acid level :
In male - less than 7 mg/dl and greater than 10 mg/dl
In female – less than 6 mg/dl and greater than 10 mg /dl.
5. Patients with known case of Vatarakta with chronicity more than 1 year.
6. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sandhiruja (Pain) Sparshasahatva(Tenderness) Sandhidaha(Burning sensation)
this lakshanas will be decreased |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sandhishotha(Swelling)
Sandhistabdhata(Stiffness) this lakshanas will be decreased
|
21 days |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
01/06/2025 |
| 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
|
Due to rapid modernisation in India fast food culture, stressful and sedentary lifestyle the disturbance in samavastha of dosha’s cause various diseases and Vatarakta is one of them.Vatarakta is made of two words Vata and Rakta .The disease which is caused by aggaravated Vata and vitiated Rakta due to its own causative factors is termed as Vatarakta. It is also known as Khudaroga, Vata-balasa, Vatashonita and Adhyavata. Vatarakta is one of the main articular joint metabolic disease which is characterized by severe pain, tenderness, inflammation in the affected joints .Due to critic nature of disease, people became disabling in the routine activities and ultimately it affects the quality of life. The chief complaints of patient is severe joint pain with onset from hasta-pada angustha mula and then it migrates to other joints in a way similar to Akhuvisha. The above clinical presentation to textual reference of the disease can be easily correlate with Gout explained in modern medicine. As we know Gout results due to deposition of monosodium urate crystal (MSU) in joints secondary to hyperuricemia, which results due to inappropriate purine metabolism. Hyperuricemia may occur either due to excessive production or decreased excretion of uric acid .The most common type of inflammatory monoarthritis is caused by monosodium urate crystals characterized by pain or swelling of 1st metatarsal joint and then progress to other joints of body. NULL HYPOTHESIS - There
is no significant role of DHATRYADI KWATHA in
management of Vatarakta. ALTERNATE HYPOTHESIS - There
is significant role of DHATRYADI KWATHA in
management of Vatarakta. The study will be conducted on 92 patients with 46 patients of trial group will be treated with Dhatryadi kwatha and the other 46 patients of Control group will be treated with Kaishor guggul and the result will be conducted. |