| CTRI Number |
CTRI/2021/04/032955 [Registered on: 20/04/2021] Trial Registered Prospectively |
| Last Modified On: |
19/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of Basti and Shamana yoga in Rheumatoid Arthritis |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Effect Of Panchamuladi Basti And Vaishvanara Churna In The Management Of Amavata w.s.r. To Rheumatoid Arthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pushpinder Singh |
| Designation |
H.O.D ,Panchkarma Department |
| Affiliation |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital ,Paprola |
| Address |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital ,Paprola
RGGPG Ayurvedic college and hospital, paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8580789117 |
| Fax |
|
| Email |
drpushpinderpk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushpinder Singh |
| Designation |
H.O.D ,Panchkarma Department |
| Affiliation |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital ,Paprola |
| Address |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital ,Paprola
RGGPG Ayurvedic college and hospital, paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8580789117 |
| Fax |
|
| Email |
drpushpinderpk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas |
| Designation |
2nd year PG Scholar ,Deptt. of Panchkarma |
| Affiliation |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital ,Paprola |
| Address |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital ,Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8054864399 |
| Fax |
|
| Email |
vk48768@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, RGGPG Ayurvedic College and Hospital,Paprola,Kangra (H.P) |
| M/s Shashi Pal Gourav Kumar KARYANA & PANSARI MERCHANTS Khoo Bazar PAPROLA Teh.Baijnath Distt.Kangra (H.P.) |
| Research Institute in I.S.M. Jogindernagar (H.P.) |
|
|
Primary Sponsor
|
| Name |
Principal Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic college and Hospital, Paprola, Distt. Kangra, Himachal Pradesh 176115 |
| 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 |
| Prof Pushpinder Singh |
RGGPG Ayurvedic College and Hospital Paprola |
Room no 203 HOD Department of Panchkarma
RGGPG Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH |
8580789117
drpushpinderpk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC (human) RGGPG Ayurvedic College Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D899||Disorder involving the immune mechanism, unspecified. Ayurveda Condition: Aamvata, (2) ICD-10 Condition:D899||Disorder involving the immune mechanism, unspecified. Ayurveda Condition: AMAVATAH, (3) ICD-10 Condition:D899||Disorder involving the immune mechanism, unspecified. Ayurveda Condition: AMAVATAH, (4) ICD-10 Condition:D899||Disorder involving the immune mechanism, unspecified. Ayurveda Condition: AMAVATAH, (5) ICD-10 Condition:D899||Disorder involving the immune mechanism, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Basti-16 days |
Panchamuladi Niruha Basti -6
Dwipanchamuladya tail Anuvasna Basti-10 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vaishvanara churna |
Vaishvanara churna 3 gm BD with Luke warm water for 16 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing for study.
2.Age group 18-70 years irrespective of sex,education, religion, socioeconomic status etc.
3.Patients with signs and symptoms of Amavata(Rheumatoid arthritis)
4.Written informed consent of the patients will be obtained before inclusion in the study. |
|
| ExclusionCriteria |
| Details |
1.Patients not willing for the study.
2.Patients below age of 18 years and above 70 years of age.
3.Patients suffering from cardiac,respiratory and any infectious disease.
4.Malignancy.
5.Patients already taking chemotherapy, radiotherapy.
6.Pregnant and lactating women.
7.Allergy to the research drug. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of objective and subjective criteria |
16 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General feeling of well being |
31 days |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
20/04/2021 |
| 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="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. One group of 10 patients will be assessed on the basis of inclusion and exclusion criteria to know the effect of Basti and Shamana yoga. |