| CTRI Number |
CTRI/2024/12/078068 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study to evaluate efficacy of Simhasyadi kwath and kokilakshadi kwath in the management of Uttana Vatarakta(Gout) |
|
Scientific Title of Study
|
A Randomized comparative clinical study to evaluate efficacy of Simhasyadi kwath and kokilakshadi kwath in the management of Uttana 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.Saloni Santosh Shah. |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindaji Raoji Ayurved Mahavidyalaya,Solapur |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rughnalaya,
118/119 Shukrawar peth,near juni faujdar chawadi,Solapur,Maharashtra,India
Solapur
MAHARASHTRA
413002
India |
| Phone |
9421664022 |
| Fax |
|
| Email |
saloni.shah@pg.sgrayurved.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSantosh Swami |
| Designation |
Associate Professor,Kayachikitsa Department |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalay |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119 Shukhwar Peth, Near Faujdar Chawdi, Solapur
Solapur
MAHARASHTRA
413002
India |
| Phone |
9422957234 |
| Fax |
|
| Email |
santosh.swami@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saloni Santosh Shah |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalay |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119 Shukhwar Peth, Near Faujdar Chawdi, Solapur
Solapur
MAHARASHTRA
413002
India |
| Phone |
9421664022 |
| Fax |
|
| Email |
saloni.shah@pg.sgrayurved.edu.in |
|
|
Source of Monetary or Material Support
|
| Seth Sakharam Nemchand Jain Ayurved Rughnalaya,118/119 Shukrawar peth,near juni faujdar chawadi,Solapur,Maharashtra-413002 |
|
|
Primary Sponsor
|
| Name |
DrSaloni Santosh Shah |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rughnalaya,118/119 Shukrawar peth,near juni faujdar chawadi,Solapur, Maharashtra-413002 |
| 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 |
| DrSaloni Santosh Shah |
Seth Sakharam Nemchand Jain Ayurved Rughnalaya |
All OPDs From,
Seth Sakharam Nemchand Jain Ayurved Rughnalaya118/119 Shukrawar peth,near juni faujdar chawadi,Solapur
Solapur
MAHARASHTRA |
9421664022
saloni.shah@pg.sgrayurved.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seth Govindji Raoji Ayurved Mahavidyalaya Ethical Committee |
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: Simhasyadi kwath, Reference: Bhavprakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Erand Sneha,Hingu,Saindhav), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kokilakshadi Kwath, Reference: Yogratnakara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -koshnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Participants with classical sign & symptoms of Uttana Vatarakta i.e., Sandhi Shula, Sandhi Shoth, Sandhi daha, Sandhi sparsahatva, Sandhivaivarnya will be selected.
2)Participants with classical sign & symptoms of Vatarakta having raised serum Uric acid level. |
|
| ExclusionCriteria |
| Details |
1)Participants who are suffering from any other known case of Immunosuppressed disease.
2)Pregnant and lactating women.
3)Participants taking uricosuric/xanthine oxidase inhibitor drugs and also immunosuppressive medications.
4)Participant diagnose with other than Gouty Arthritis such as Rheumatoid arthritis, Osteoarthritis, Systemic Lupus Erythematosus.
5)Complicated cases of Vatarakta by its upadravas like Mansakoth, Murchha, Moha, Visarpa, Pangulya etc.
6)Patient with uncontrolled comorbidities like Diabetes Mellitus, Hyper Tension. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)To study the efficacy of Simhasyadi Kwath and Kokilakshadi Kwath in reducing the Serum uric acid level & classical symptoms of Gout. |
21 Days with Follow-up on 7th, 14th and 22nd day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study the safety of Simhasyadi Kwath and Kokilakshadi Kwath in the cases of Gout.
2)To understand Samprapti of Uttana Vatarakta in detail.
3)To understand Etiopathology of Gout in detail. |
21 Days with Follow-up on 7th, 14th and 22nd day. |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/12/2024 |
| 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="11"
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
|
Illness has been human heritage from the beginning of his existence, and search for remedies to combat is perhaps equally old. Ample researches have been done till now on Vatarakta (Gout), still due to the adaptation of sedentary life style along with mental stress, consumption of non veg and highly rich protein diet, excessive alcohol intake are some of the precipitating factors which causes acute exacerbation of Vatarakta hence in present Era the condition is still on the high prevalence worldwide. Currently in modern science non-steroidal anti-inflammatory drugs, Colchicine, Corticosteroids are being used to treat Gout. These medications may causes side effects such as Gastro Intestinal bleeding, Vomiting, Hepatotoxicity. Therefore, it is necessary to find Proper Intervention which should be more effective and with fewer drawbacks. Ayurveda has advocated many formulations to manage Vatarakta condition which can be helpful in finding out better solution in the management of Gout also. The drug Simhasyadi Kwath is selected for present clinical trial which consists of ingredients like Vasa, Laghupanchmool, Erandmool, Guduchi, Gokshur and praksheparth Erand tail, Saindhav, Hingu work together synergistically and are very beneficial in treating Shula, daha and Shotha yukt joints. The ingredients of this formulation possess the qualities like Vedanasthapan, Shothahar, Raktashodhana, Vatanulomana. |