| CTRI Number |
CTRI/2021/08/035594 [Registered on: 11/08/2021] Trial Registered Prospectively |
| Last Modified On: |
04/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of two ayurvedic formulation in gout |
|
Scientific Title of Study
|
"Comparative evaluation of the efficacy of kaishore guggulu,giloyghan vati and bodhivriksha kashaya with madhu in primary hyperuricemia (Vatarakta)" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajani Agrahari |
| Designation |
MD Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
| Address |
OPD 12 Department of Kayachikitsa
Patanjali Ayurvedic Hospital
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar- 249402
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7088506942 |
| Fax |
|
| Email |
rajniagarhari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Bhushan Sharma |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
| Address |
OPD 12 Department of Kayachikitsa
Patanjali Ayurvedic Hospital
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar- 249402
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9458636020 |
| Fax |
|
| Email |
ayu.abhishek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Bhushan Sharma |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
| Address |
OPD 12 Department of Kayachikitsa
Patanjali Ayurvedic Hospital
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar- 249402
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9458636020 |
| Fax |
|
| Email |
ayu.abhishek@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayurvedic Hospital
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurvedic College |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar-249405 |
| 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 Rajani Agrahari |
Patanjali Ayurved Hospital |
OPD no.12 Department of Kayachikitsa
Patanjali Ayurvedic Hospital
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar- 249402
Hardwar
UTTARANCHAL |
7088506942
rajniagarhari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PAC/IEC/2019-20/12 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E790||Hyperuricemia without signs of inflammatory arthritis and tophaceous disease. Ayurveda Condition: GOUT(PRIMARY HYPERURICEMIA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Group A- Kaishore Guggulu,Giloyghan Vati, Reference: G.Prabhakara Rao Bhaisajya Ratnavali of Kaviraj Shri Govind Das Sen vol-I first editions 2014 (Reprint edition: 2019) Chaukhambha orientalia Varanasi chp 27, pg no. 797 shloke no.98-108, Route: Oral, Dosage Form: Guggulu , Dose: 375(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Group B - Bodhivriksha Kashaya, Reference: Charak Samhita Chikitsa Sthana (29/158), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: With Madhu), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between the age group of 18 -70 years will be selected.
2.Patients having serum uric acid > 7mg/dl in male and> 6mg/dl in female or more
than upper normal limit.
3.Patients not having any associated chronic ailment.
4.Patient with symptoms of Vatarakta and primary hyperuricaemia will be selected
for the study.
5.Patients irrespective of sex, religion, occupation will be selected for the study. |
|
| ExclusionCriteria |
| Details |
1.Patients aged < 18 years or> 70 years will be excluded.
2.Pregnant or lactating mother will be excluded.
3.Patients with renal disorder, liver disease, osteoarthritis, rheumatoid arthritis, Diabetes mellitus, obesity, hypothyroidism or hyperthyroidism, chronic haemolytic anaemia, auto immune disorders, and any other co-morbid condition will be excluded. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters-
1.Itching
2.Pain
3.Burning sensation
4.Malaise
Objective Parameters-
1.Sign of primary hyperuricemia
Tenderness
Local colour changes in the skin
2.Serum uric acid before the treatment
|
Before intervention with Kaishore guggulu, giloyghan vati and Bodhivriksha Kashaya |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters-
1.Itching
2.Pain
3.Burning sensation
4.Malaise
Objective Parameters-
1.Sign of primary hyperuricemia
Tenderness
Local colour changes in the skin
2.Serum uric acid after the treatment
|
After intervention of 1 month with Kaishore guggulu, giloyghan vati and Bodhivriksha Kashaya |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
18/08/2021 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Group-A - 2-2 tablet each of Kaishore guggulu and Giloy ghan vati will be given to the patients.
Group-B - 40 ml of Bodhivriksha kashaya with 2 tsf madhu will be given to the patients.
Kaishor guggulu and Giloy ghan vati will be advice to take 1 st dose in morning at 9:00 a.m. and 2 nd dose at 9:00 p.m. after having breakfast.
Bodhivriksha kashaya with madhu will be advice to take 1 st dose in the morning at 6:00 a.m. and 2 nd dose at 6:00 p.m. on empty stomach.
Route of administration- oral Follow up : The follow up will be done after 15 days and 1 month during the trial of 1 month to observe the effects of treatment or any adverse effects on the patients. |