| CTRI Number |
CTRI/2022/07/043885 [Registered on: 11/07/2022] Trial Registered Prospectively |
| Last Modified On: |
08/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study of drug Eranda for the treatment in patients of Aamvata and Vatarakta |
|
Scientific Title of Study
|
A comparative pharmaco- clinical study of eranda mool(Ricinus communis Linn.) in the management of Aamvata and 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 Anubhav |
| Designation |
MD Scholar |
| Affiliation |
Post graduate training and research institute Government Ayurvedic College, Patiala |
| Address |
PG Dravyaguna of Department,
Post graduate training and research institute
Government Ayurvedic College
Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9872955005 |
| Fax |
|
| Email |
anubhav.salhotra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rosy Gupta |
| Designation |
Reader |
| Affiliation |
Post graduate training and research institute Government Ayurvedic College, Patiala |
| Address |
PG Dravyaguna of Department
Post graduate training and research institute
Government Ayurvedic College
Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9815818190 |
| Fax |
|
| Email |
rrgu04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rosy Gupta |
| Designation |
Reader |
| Affiliation |
Post graduate training and research institute Government Ayurvedic College, Patiala |
| Address |
PG Dravyaguna of Department
Post graduate training and research institute
Government Ayurvedic College
Patiala
Punjab
Patiala
PUNJAB
147001
India |
| Phone |
9815818190 |
| Fax |
|
| Email |
rrgu04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College, Patiala, Punjab |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College |
| Address |
Government Ayurvedic College, Patiala, Punjab, 147001 |
| Type of Sponsor |
Government medical college |
|
|
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 Anubhav |
Government Ayurvedic Hospital, Patiala |
Room no. 7, Ground floor Department of Kayachiktsa, Government Ayurvedic Hospital, Patiala, Punjab, 147001
Patiala
PUNJAB |
9872955005
anubhav.salhotra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, No,4065 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M241||Other articular cartilage disorders. Ayurveda Condition: AMAVATAH, vAtarakta, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Eranda , Reference: Madanpala nighabtu Abhyadi varga 1/95-96, madanadi nighantu ashtama gana 8/5-8, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with written consent, 2.Having clinical features of Amavata or Vatarakta, 3.Patients fulfilling subjective and objective criteria like sandhi shool, shotha, sandhi stabhdhata etc. in amavata and Sandhi graha, twaka vaivrnaya, raga etc. in vatarakta |
|
| ExclusionCriteria |
| Details |
1.Patients below 30 and above 70 years of age
2. Pregnant and lactating mothers
3. Patients with serious systemic illness
4. Patients with complications of Amavata and Vatarakta |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Parameter- Grading will be done with signs and symptoms of both Amavata and Vatarakta respectively.
RA Factor, CRP, ESR for Amavata and Uric Acid levels for Vatarakta |
After one month intervention of Erandamool kwatha orally and 15 days after stopping of medicine
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective Parameter- Grading will be done with signs and symptoms of both Amavata and Vatarakta respectively.
RA Factor, CRP, ESR for Amavata and Uric Acid levels for Vatarakta. |
After one month intervention of erandamool Kwatha orally, and 15 days after stopping of medicine. |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/07/2022 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this trial we are selecting patients of Amavata and Vatarakta separately in two groups, In which we will do intervention study of study with drug Eranda mool in the form of Kwath preparation, with the Dose of 50 ml. BID. Assessment will be done on the subjective and objective parameters for both the diseases individually. Route of administration - ORAL Follow up - Day 15, Day30 while taking medicine and after 15 days after stopping of medicicne. |