| CTRI Number |
CTRI/2024/04/066557 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
“Role of Guduchi Ksheer Taila and Tila Taila Matra Basti in Reducing Uric Acid in Gout Patients – A Clinical Study” |
|
Scientific Title of Study
|
A COMPARATIVE OPEN LABELLED STUDY
OF GUDUCHI KSHEER TAIL AND TIL
TAILMATRA BASTI IN THE MANAGEMENT
OF VATARAKTA WITH SPECIAL REFERENCE
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 Subodh Chandrakant Patil |
| Designation |
Professor Ph.D. (Scholar) |
| Affiliation |
A P M s Ayurved College Sion Mumbai |
| Address |
Department Of Panchakarma . D C S Dayasagar educational Compus Smt K C Ajmera Ayurved Mahavidyalaya and hospital , old agra road deopur dhule
Dhule
MAHARASHTRA
424002
India |
| Phone |
940350079 |
| Fax |
|
| Email |
drsubodh77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj P. Tathed |
| Designation |
Ph.D. guide Assistant Lecturer |
| Affiliation |
A P M s Ayurved College Sion Mumbai |
| Address |
Department Of Panchakarma
Ayurveda Prasarak Mandals Ayurveda Mahavidyalaya near sion railway station sion, mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8928783687 |
| Fax |
|
| Email |
drpankajtathed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subodh Chandrakant Patil |
| Designation |
Professor Ph.D. (Scholar) |
| Affiliation |
A P M s Ayurved College Sion Mumbai |
| Address |
Department Of Panchakarma . D C S Dayasagar educational Compus Smt K C Ajmera Ayurved Mahavidyalaya and hospital , old agra road deopur dhule
Dhule
MAHARASHTRA
424002
India |
| Phone |
940350079 |
| Fax |
|
| Email |
drsubodh77@gmail.com |
|
|
Source of Monetary or Material Support
|
| D C S Dayasagar educational Compus Smt K C Ajmera Ayurved Mahavidyalaya and hospital , old agra road deopur dhule maharashtra india 424002 |
|
|
Primary Sponsor
|
| Name |
Dr subodh Chandrakant Patil |
| Address |
35 b Pramod Nagar Sector number 2 pingale marga Deopur Dhule 424002 |
| Type of Sponsor |
Other [professor and Ph D aspirant] |
|
|
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 Subodh Chandrakant Patil |
Smt.K.C. Ajmera Ayurveda Mahavidyalaya and Hospital |
Department of Panchakarma D C S s K C Ajmera Ayurved Mahavidyalaya and Hospital Dayasagar Educational Campus , Old Agra road , Neharu Chawk Deopur Dhule 424002
Dhule
MAHARASHTRA |
9403500079
drsubodh77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt. K C Ajmera Ayurveda Mahavidyalaya Dhule |
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 | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charaka Chikitsa 29/89, Procedure details: Guduchi Ksheer Tail Matra Basti will be administered after breakfast once in morning after sthanik snehana with til tail and swedana with Dashamool Kashya in dose of 60 ml for 15 days daily)
(1) Medicine Name: Guduchi Ksheer Tail , Reference: Charak Chikitsa 29/121, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charaka Chikitsta Sthana 29/89, Procedure details: Til Tail Matra Basti will be administered after breakfast once in morning after sthanik snehana with til tail and swedana with Dashamool Kashaya in dose of 60 ml for 15 days daily)
(1) Medicine Name: Til Tail, Reference: Charak Chikitsa 29/90, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients presenting features as Vatarakta as per text
2) Irrespective of sex.
3) Willing to participate.
|
|
| ExclusionCriteria |
| Details |
1) Pregnancy and Lactation
2) patients of severe anorectal disorders
3) Major systemic diseases.
4) All arthritic conditions other than Vatarakta
5) chronic renal disorders. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome measure will be rated using the
Assessment criteria
A) Subjective (Day 0, Day 16, Day30)
Visual analogue scale (1to 10)
Presentation at affected joints
1. Swelling (Shotha)
2. Pain (Pida, Daha,Toda)
3. Stiffness (Kathinya)
4. Tenderness (Sparshasahatva)
5. Functional score (Ability to perform joint functions)
Objective Criteria
Following objective criteria will be assessed on day 0, day16, day30
Lab investigation
a. Serum uric acid level
b. Erythrocyte Sedimentation Rate (By Win Trobe Method)
c. Complete Blood Count
Health assessment questionnaire disability index (H A Q DI |
The primary outcome measure will be rated using the
Assessment criteria
A) Subjective (Day 0, Day 16, Day30)
Visual analogue scale (1to 10)
Presentation at affected joints
1. Swelling (Shotha)
2. Pain (Pida, Daha,Toda)
3. Stiffness (Kathinya)
4. Tenderness (Sparshasahatva)
5. Functional score (Ability to perform joint functions)
Objective Criteria
Following objective criteria will be assessed on day 0, day16, day30
Lab investigation
a. Serum uric acid level
b. Erythrocyte Sedimentation Rate (By Win Trobe Method)
c. Complete Blood Count
Health assessment questionnaire disability index (H A Q DI |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| secondary outcomes were health assestment questionnarire disability index subscale (pain , Stiffness etc )also safety ( adverse events and serious adverse events ) are assessed. |
secondary outcomes will be assedssed at base line,0 , 16 and 30 day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
Modification(s)
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 this modern era, the incidence of patients suffering from Vatarakta are increasing on a steady pace. Vatarakta is a metabolic disorder where pain is pre dominant symptom , which disturbs day today life of the affected individuals .Considering the clinical presentation and textual references of Vatarakta , it can be correlated with Gout explained in modern medicine. As panchakarma is the classical and effective cleansing modality to break down path-physiology of gout ,The simplest type of basti matra basti as a panchakarma selected for the present study .There are various formulations mentioned in Samhitas among which I have selected Guduchi Ksheer Tail and til tail as Matra Basti in Gout. To compare the effect of guduchi ksheer tail and til tail matra basti in Vatarakta in terms of serum uric acid levels . Is there any difference in the effects of guduchi ksheer tail and til tail matra basti ? There is significant difference in the effects of Guduchi Ksheer Tail and Til Tail matra basti . |