| CTRI Number |
CTRI/2023/04/051839 [Registered on: 21/04/2023] Trial Registered Prospectively |
| Last Modified On: |
20/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Biological Ayurveda Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of virechan and jaluka along woth gorakh mundi churan and guduchi kwath in treatment of vatarakta |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the effect of virechan and jalukavacharana with shamana aushadhi Gorakh Mundi Churana nad Guduchi Kwatha in management of Vatarakta w.s.r. to Gout |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Charu Supriya |
| Designation |
Lecturer Panchkarma Department |
| Affiliation |
RGGPG Ayurvedic College and hospital Paprola |
| Address |
RGGPG Ayurvedic college and hospital Paprola
Teh Baijnath Distt Kangra RGGPG Ayurvedic College and hospital Paprola Baijnath Kangra HIMACHAL PRADESH 176115 India |
| Phone |
8894242782 |
| Fax |
|
| Email |
charusupriya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Charu Supriya |
| Designation |
Lecturer Panchkarma Department |
| Affiliation |
RGGPG Ayurvedic College and hospital Paprola |
| Address |
RGGPG Ayurvedic college and hospital Paprola
Teh Baijnath Kangra
RGGPG Ayurvedic College and hospital Paprola Baijnath
Kangra HIMACHAL PRADESH 176115 India |
| Phone |
8894242782 |
| Fax |
|
| Email |
charusupriya@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Anupam Thakur |
| Designation |
PG Scholar |
| Affiliation |
Rajiv gandhi ayurvedic college and hospital paprola |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College Paprola Kangra Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital paprola Kangra HIMACHAL PRADESH 176115 India |
| Phone |
8263045985 |
| Fax |
|
| Email |
rajputanu2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath pharmacy ,Paprola District Kangra ,Himachal Pradesh |
| Charak pharmacy ,Rajiv Gandhi ayurvedic College and Hospital,Paprola District
-Kangra,Himachal Pradesh |
| Research Institute in I.S.M Jogindernagar,Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Principal RGGPG Ayurvedic College and Hospital Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola |
| 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 Charu Supriya |
Rajiv Gandhi Ayurvedic College and Hospital |
Room no.203 Lecturer
Department of
Panchkarma,RGGPG
Ayurvedic College and
Hospital
Kangra
HIMACHAL PRADESH Kangra HIMACHAL PRADESH |
8894242782
charusupriya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC(human) RGGPG Ayurvedic College Paprola |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E70||Disorders of aromatic amino-acid metabolism. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Jalukavcharana | (Procedure Reference: Charak chikitsa 29/36, Procedure details: Local application )
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gorakh mundi churna , Reference: Chakradatta chikitsa 23 /6, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchi Kwatha , Reference: Chakradatta chikitsa 23 /6, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gorakh mundi churna , Reference: Chakradatta chikitsa 23 /6, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu ), Additional Information: -(2) Medicine Name: Guduchi kwath , Reference: Chakradatta chikitsa 23 /6, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 5 | Intervention Arm | Procedure | - | snehapAna-karma, सà¥à¤¨à¥‡à¤¹à¤ªà¤¾à¤¨-करà¥à¤® | (Procedure Reference: Charak chikitsa 29 /41, Procedure details: Snehapana with Shatavari Ghrita) (1) Medicine Name: Shatavari Ghrita, Reference: Chakradatta chikitsa 23 /25, Route: Oral, Dosage Form: Ghrita, Dose: 40(ml), Frequency: od, Duration: 7 Days | | 6 | Intervention Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: Charak chikitsa 29/41, Procedure details: Abhyanga with Murchis Til Tail ) (1) Medicine Name: Til tail, Reference: Bhaishjya ratnavali 5/1286-87, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 4 Days | | 7 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® Pradhan Karma | (Procedure Reference: Charak kalp 8 /11, Procedure details: (1) Medicine Name: Virechan yoga, Reference: Charak kalp 8 /11, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: -Aargavdh Phall Majja ), Additional Information: -virechana) (1) Medicine Name: Arun trivat kwath , Reference: Charak kalp 8/11, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing for study.
Patients having classical signs and symptoms of Vatarakta.
Only uncomplicated cases of Vatarakta w.s. r. to Gout will be taken in the study . |
|
| ExclusionCriteria |
| Details |
1. Patients not willing for the study. 2. Patient presenting with systemic complications like Ischemic Heart
Disease, Uncontrolled
Hypertension.
Chronic Kidney Disease,
3. Patients below the age of 20 years and above 60 years.
Uncontrolled Diabetes Mellitus, Liver disorder.
4. Pregnancy.
5. Mentally unstable and substance abused patients. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of objective and subjective criteria |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General feeling of well-being |
45 days |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/04/2023 |
| 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="0" 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
|
I would like to publish my research trial after completion of the trial as soon as possible .Patients will be selected from campus/faculty/OPD of RGGPG Ayurvedic College and Hospital ,Paprola.Two groups of 20 patients will be assessed on the basis of inclusion and exclusion criteria to know the comparative effect of virechana and jalukavcharana with shamana yoga. |