| CTRI Number |
CTRI/2024/11/076688 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see and Compare the effect of Balaguduchiyadi oil and Guduchi oil administered through rectal route in treatment of gout |
|
Scientific Title of Study
|
A clinical comparative study of efficacy of Balaguduchiyadi Taila and
Guduchi Taila Matra basti in the managment of Vatarakta w.s.r. 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 |
Dr Priyanka Jagawanta Pal |
| Designation |
Post graduate resident |
| Affiliation |
APMs Ayurveda Mahavidyalaya, Near sion railway station, sion east, mumbai |
| Address |
Department of Panchakarma,
Second floor, APMs Ayurveda Mahavidyalaya, Near sion railway station, sion east, mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8390718333 |
| Fax |
|
| Email |
pal.priyanka53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwajeet Jayavant Patade |
| Designation |
Professor |
| Affiliation |
APMs Ayurved mahavidyalaya sion |
| Address |
Department of Panchakarma,
Second floor, APMs Ayurved Mahavidyalaya, near sion
railway station, sion east, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9869055701 |
| Fax |
|
| Email |
drvishup@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishwajeet Jayavant Patade |
| Designation |
Professor |
| Affiliation |
APMs Ayurved mahavidyalaya sion |
| Address |
Department of Panchakarma,
Second floor, APMs Ayurved Mahavidyalaya, near sion
railway station, sion east, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9869055701 |
| Fax |
|
| Email |
drvishup@gmail.com |
|
|
Source of Monetary or Material Support
|
| APMs Ayurved Mahavidyalaya Sion near sion railway station sion east mumbai 400022 Maharashtra India
|
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Jagawanta Pal |
| Address |
APMs Ayurved Mahavidyalaya Sion, Near sion railway station, sion
east, Mumbai - 400022 |
| 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 Priyanka Jagawanta Pal |
seth R V Ayurvedic Hospital sion |
Department of
Panchakarma,OPD no 1,
near sion railway
station, sion Mumbai 400022
Mumbai
MAHARASHTRA |
8390718333
pal.priyanka53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya sion IEC |
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 | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charak Siddhisthan Adhyay 3 shlok number 28, Procedure details: Purva karma (pre- operative)
1 Patients vital will be taken
2 Sthanik snehan with tila oil and sthanik swedana of nitamb,prushta,kati , will be done
3 Patient will be made to lie in left lateral position
3 Warm balaguduchyadi oil of 60 ml will be added in the basti putak (syringe)
4 Lubrication of catheter will be done.
Pradhan karma (operative)
1 lubricated catheter will be inserted upto the 4.5cm into the anal region parallel to spine.
2 By gently pushing the oil by applying uniform pressure , patient will be asked to take slow deep breath
3 catheter will be removed slowly.
Paschat karma (Post operative)
1 patting/massaging of the buttocks will be done.
2 Patient will be asked to sleep in supine position for 10min
)
(1) Medicine Name: GUDUCHI TAILA, Reference: Chakradatta vataraktarogadhikar Shlok number 67, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charak siddhisthan Adhyay 3 Shlok no 28, Procedure details: Purva karma (pre- operative)
1 Patients vital will be taken.
2 Sthanik snehan with tila oil and sthanik swedana of nitamb,prushta,kati , will be done.
3 Patient will be made to lie in left lateral position.
3 Warm balaguduchyadi oil of 60 ml will be added in the basti putak (syringe).
4 Lubrication of catheter will be done.
Pradhan karma (operative)
1 lubricated catheter will be inserted upto the 4.5cm into the anal region parallel to spine.
2 By gently pushing the oil by applying uniform pressure , patient will be asked to take slow deep breath.
3 catheter will be removed slowly.
Paschat karma (Post operative)
1 patting/massaging of the buttocks will be done.
2 Patient will be asked to sleep in supine position for 10 min
)
(1) Medicine Name: BALAGUDUCHIYADI TAILA, Reference: Sahastra Yoga Pancham prakarna Taila yoga Balaguduchiyadi Taila, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants with symptoms of vatarakta.
Gender- both male and female
Age-18 to 70 yrs.
Participants with uric acid level of Female greater than 6 mg/dl and Male greater than 7mg/dl. |
|
| ExclusionCriteria |
| Details |
Patient of vatarakta involving any structural deformity
Patient with uncontrolled hypertension, diabetes mellitus
Pregnant women, lactating mother and during menstrual cycle
Patient having any ano-rectal bleeding, fistula, adhog raktpitta
Patient with known case of HIV, HBSAG, CKD, liver failure |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| serum uric acid level |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sandhishoola(Joint pain)
Sandhigraha (joint stiffness)
Sandhitamravarnata
Sandhisparshasahtva (Tenderness)
Sandhikriyakashta (loss of movement)
Sandhishotha(swelling)
Daha (Burning pain)
|
14 days |
|
|
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 4 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="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
|
According to modern science colchine given the management of acute gout. The most common adverse effects of this drugs are nausea, vomiting and diarrhoea. Patient with recurrent episode can keep supply of analgesics, NSAID’S, cox inhibitor and xanthine oxidase inhibitors etc. local NSAIDS are effective but used less commonly since many patients affected by acute gout have co existing cardiovascular, cerebrovascular or CKD. In chronic patient of gout, the ayurvedic management will be helpful. Since ayurveda is holistic science, it has better approach of treatment for gout according to patient Acharya yogratnakar has mentioned administration of ruksha or mrudu basti karma in the management of vatarakta. Basti karma is consider as one of the best treatments for vatrakta. so, basti of balaguduchyadi taila and guduchi taila is used and its compartive effect will be monitored on patient of vatarakta |