| CTRI Number |
CTRI/2014/02/004388 [Registered on: 07/02/2014] Trial Registered Retrospectively |
| Last Modified On: |
17/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to see the effect of some Ayurvedic formulations in the management of Arthritis knee. |
|
Scientific Title of Study
|
Clinical evaluation of Vatari guggulu, Maharasnadi Kwatha and Narayan taila in the management of Osteoarthritis knee. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Mangal |
| Designation |
Research Officer (Ayurveda) S-2 |
| Affiliation |
Central council for Research in Ayurvedic Sciences(CCRAS) |
| Address |
National Research Institute for Ayurveda-siddha Human Resource Development & Hospital, Amkho, Gwalior
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9755412502 |
| Fax |
0751-2430317 |
| Email |
dranilmangal1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Mangal |
| Designation |
Research Officer (Ayurveda) S-2 |
| Affiliation |
Central council for Research in Ayurvedic Sciences(CCRAS) |
| Address |
National Research Institute for Ayurveda-siddha Human Resource Development & Hospital, Amkho, Gwalior
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9755412502 |
| Fax |
0751-2430317 |
| Email |
dranilmangal1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Mangal |
| Designation |
Research Officer (Ayurveda) S-2 |
| Affiliation |
Central council for Research in Ayurvedic Sciences(CCRAS) |
| Address |
National Research Institute for Ayurveda-siddha Human Resource Development & Hospital, Amkho, Gwalior
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9755412502 |
| Fax |
0751-2430317 |
| Email |
dranilmangal1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences,Dept.of AYUSH,Ministry of Health and Family welfare, Govt.of India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Central Council for Research in Ayurvedic Sciences, Jawahar Lal Nehru bhartiya chikitsa evam homoeopathy Anusandhan Bhawan, 61-65, Institutional area, opposite D Block, Janakpuri west, New Delhi-110058
India |
| Type of Sponsor |
Other [Research Organisation] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr pramila devi |
Dr Achanta Lakshmipati Research Centre for Ayurveda (ALRCA) & Hospital |
Department of clinical research,Adyar,chennai
Chennai
TAMIL NADU |
044-22541536
044-22541537
alrca.chennai@gmail.com |
| Dr Subhashree |
National Ayurveda Dietetics Research Institute & Hospital |
Department of clinical research,Ashoka pillar,jaya nagar,Bangalore
Bangalore
KARNATAKA |
080-26562030
044-26524478
nadri.bengaluru1@gmail.com |
| Dr Anil mangal |
National Research Institute for Ayurveda-siddha Human Resource Development & Hospital, Gwalior |
Department of Clinical Research ,Room No. 36,Amkho, Gwalior
Gwalior
MADHYA PRADESH |
0751-2323307
0751-2430317
dranilmangal1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| institutional ethics commiittee, Gwalior |
Approved |
| Institutional ethics commiittee,Bangalore |
Approved |
| Institutional ethics commiittee,chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
osteoarthritis knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Vatari guggulu along with Maharasnadi Kwatha and Narayan taila |
VATARI GUGGULU (Bhaishjya Ratnavali- Amavatadhikar) dose- 2 tablets thrice daily, dosage form-tablet of 500 mg each, route of administration –oral, time of administration-thrice a day after food, anupana-lukewarm water, duration of therapy -12 weeks
MAHARASNADI KWATHA (Bhaishjya Ratnavali- Amavatadhikar)- dose-20ml twice daily, dosage form- kwatha, route of administration- oral, time of administration twice a day after food, anupana-lukewarm water, duration of therapy-12 weeks
NARAYAN TAIL (Bhaishjya Ratnavali- Vatavyadhyadhikara)-dose 20 ml twice daily, dosage form-oil, route of administration-local gentle massage on affected joint(s) followed by hot fomentation, type of administration- twice a day at 1 hrs interval, packing form 600 ml plastic bottle |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with Primary Osteoarthritis (knee) fulfilling the diagnostic criteria of osteoarthritis recommended by the American College of Rheumatology.
2. Pain in the affected joint(s) > 3 months (with radiological changes as per Grade I to III of Kellgren & Lawrence Radiological scale).
3. Willing and able to participate in the study for 16 weeks. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in WOMAC total score |
at baseline,at 84th day and at the end of follow up after 16 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in WOMAC stiffness Domain Score
2. Change in WOMAC Physical function Domain
3. Global assessment of disease activity
Change in the visual analogue scale (VAS) for pain in last 48 hrs.
5. Assessment of change in Ayurvedic disease specific symptoms of Sandhi vata. |
At baseline,14th day,28th day,42nd day,56th day,70th day,84th day and at the end of follow up after 16 weeks. |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/09/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published in Journal of ayurveda in integrative medicine(J-AIM) 2017;8;200-204 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
is an open label interventional study for evaluating the safety and efficacy of
classical Ayurvedic therapeutic regimen consisting of Vatari guggulu 500 mg 2
tablets thrice a day, Maharasnadi kwatha 20 ml twice a day, local application
of Narayan taila for 12 weeks in 180 patients with Osteoarthritis knee. The
trial will be conducted in three centers. In this proposed study the
effect of this combination will be
evaluated for clinical response and change in the quality of life by using
standard parameters. The primary outcome measures will be change in WOMAC total
score. The secondary outcomes will be change in WOMAC stiffness domain score, change
in WOMAC physical function Domain, global assessment of disease activity, change
in the visual analogue scale(VAS) for pain in last 48 hrs. and Ayurvedic
disease specific symptoms at the end of 14th day,28th
day,42nd day,56th day, 70th day and 84th
day and after 4 weeks of follow-up without the trial regimen. |