| CTRI Number |
CTRI/2013/12/004241 [Registered on: 24/12/2013] Trial Registered Retrospectively |
| Last Modified On: |
16/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trial to study the effect of Ksheerbala Taila Matra Basti and Therapeutic Combination of Vatari Guggulu, Maharasnadi Kwatha and Narayan Taila in the Management of Osteoarthritis Knee |
|
Scientific Title of Study
|
Clinical Evaluation of Ksheerbala Taila Matra Basti, Therapeutic Combination of Vatari Guggulu, Maharasnadi Kwatha and Narayan Taila in the Management of Osteoarthritis Knee |
| Trial Acronym |
Not Given |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Savita Sharma |
| Designation |
RO (Ay) S-2 |
| Affiliation |
Ayurveda Mental Health Research Institute |
| Address |
Ayurveda Mental Health Research Institute,
Near Gharkul Parisar, NIT Complex,
Nandanvan, Nagpur
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9422823964 |
| Fax |
0712-2714230 |
| Email |
savitashirish@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sulochana Bhat |
| Designation |
RO (Ay) S-3, Nodal officer |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
Central Council for Research in Ayurvedic Sciences, Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan, No. 61-65, Institutional Area, Opp. "D" Block, Janakpuri, New Delhi
New Delhi
DELHI
110058
India |
| Phone |
01128525852 |
| Fax |
01128520748 |
| Email |
dr.sulochana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renu Singh |
| Designation |
R.O.(Ay) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
Central Council for Research in Ayurvedic Sciences, Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan, No. 61-65, Institutional Area, Opp. "D" Block, Janakpuri, New Delhi
New Delhi
DELHI
110058
India |
| Phone |
01128525852 |
| Fax |
01128520748 |
| Email |
drrenusingh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan, No. 61-65, Institutional Area, Opp. "D" Block, Janakpuri, New Delhi 110058, India
Telephone: 91-011-28525852/83/97/31/01
Fax : 91-011-28520748/5959
Email: ccras_dir1@nic.in
ccras_tec@nic.in
|
| 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 Savita Sharma RO Ay PI |
Ayurveda Mental Health Research Institute |
Near Gharkul Parisar, NIT Complex,
Nandanvan, Nagpur 440009
Office ph no. 0712-2714685
Office fax no. 0712-2714230
Office Email: amhri.nagpur@gmail.com
Nagpur
MAHARASHTRA |
9422823964
0712-2714230
savitashirish@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AMHRI, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, Osteoarthritis Knee (Sandhivata), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vatari Guggulu,Maharasnadi Kwatha,Narayan Taila,
Ksheerbala Taila Matra Basti |
Vatari Guggulu 500mg 2 Tablets thrice daily with Lukewarm Water after food orally for 12 weeks
Maharasnadi Kwatha 20 ml twice daily with Lukewarm Water after food orally for 12 weeks
Narayan Taila 20 ml twice daily for Local Application on affected joint(s) at 12 hrs interval, gentle massage followed by hot fomentation 12 weeks (except during matra basti days)
Ksheerbala Taila Matra Basti Snehan(oil massage) with 150ml of Lukewarm Narayan Taila for 35min to whole body followed by Sarvanga svedana with bashpa svedana (plain water steam) in the svedana kuti (Steam chamber) for 20 minutes after Sarvang Snehan Swedana 60ml of Lukewarm Ksheerbala Taila Matra Basti will be given through anus once daily (total three courses of nine days each i.e. from day 1st to 9th & 30th to 38th & 60th to 68th day during the treatment period of 12 weeks)
Pashchat Karma: After administering Matra Basti, the patient will be advised to carry out his routine work and take light meal in the evening and he/she will be called for next course of basti chikitsa |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex, aged between 30 and 65 years.
Patient with primary osteoarthritis Knee joint(s) fulfilling the diagnostic criteria of osteoarthritis recommended by the American College of Rheumatology.
Pain in the affected Knee joint(s) > 3 months (with radiological changes as per Grade I to III of Kellgren & Lawrence Radiological scale)
Willing and able to participate in the study for 16 weeks
|
|
| ExclusionCriteria |
| Details |
Patients with Grade IV Kellgren & Lawrence Radiological scale
History of any trauma/ fractured joint / surgical/diagnostic intervention with reference to the affected joint(s).
Gross disability in performing daily normal routine i.e. bedridden patients or confined to a wheelchair.
Patients with co morbidities such as gouty arthritis, rheumatoid arthritis and psoriatic arthritis.
Patients having any deformity of knee hip or back altering the gait and posture of the patient.
Patients with uncontrolled hypertension (160/100 mm of Hg).
Patients with uncontrolled diabetes mellitus{B.S. (F) 126 mg% and / or B.S. (2 hr. PP) 200 mg% and or HbA1c6.5%
Patients with evidence of malignancy.
Patients on prolonged ( 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
Patients who have a past history of atrial fibrillation, acute coronary syndrome, myocardial infarction, stroke or severe arrhythmia in the last 6 months.
Patients with any severe renal or hepatic or any other disorder which may interfere in the study.
Pregnant / lactating woman.
Patients who are currently participating in any other clinical trial.
Any other condition which the Principal Investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in WOMAC total score |
14th day, 28th day, 42nd day, 56th day, and 70th day and 84th day and after 4 weeks of follow-up study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
Assessment of change in Ayurvedic disease specific symptoms of sandhi vata
|
14th day, 28th day, 42nd day, 56th day, and 70th day and 84th day & after 4 weeks of follow-up study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/11/2013 |
| Date of Study Completion (India) |
09/03/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
09/03/2015 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Paper will be published after completion of the Project |
|
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 500mg 2 tab thrice a day, Maharasnadi kwatha 20ml twice a day, local
application of Narayan taila for 12 weeks along with the ksheer bala taila 60ml
Matra Basti Chikitsa in three
courses of nine days each (from Day 1st to 9th & 30th
to 38th & 60th to 68th day) in 60 patients with Osteo-arthritis Knee. The
trial will be conducted in Ayurveda Mental Health Research Institute, Nagpur,
India. 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 at the end of 14th day, 28th day, 42nd
day, 56th day, and 70th day and 84th day and
after 4 weeks of follow-up study. The Assessment of change in Ayurvedic
disease specific symptoms of sandhi vata
will be done at the end of 12 weeks.
Composition/Constituents of Vatari Guggulu:
VATARI GUGGULU
(AFI Part-I 5:10)
(Bhaisajyaratnavalli,
Amavatadhikara; 87.)
|
Sl. No.
|
Sanskrit name
of drug
|
Latin name
|
Parts used
|
Quantity
|
|
1
|
Vatari taila (eranda)
|
Ricinus communis
Linn
|
(Sd. oil)
|
1 Part
|
|
2
|
Gandhaka-suddha
|
Sulphur (Purified)
|
|
1 Part
|
|
3
|
Pura (Guggulu)-suddha
|
Commiphora
wightii
|
(Exd.)
|
1 Part
|
|
4
|
Haritaki
|
Terminalia
chebula Retz
|
(P.)
|
1 Part
|
|
5
|
Bibhitaka
|
Terminalia
belerica Roxb.
|
(P.)
|
1 Part
|
|
6
|
Amalaki
|
Emblica
officinalis Gaertn
|
(P.)
|
1 Part
|
Method of preparation:
Guggulu is made soft by adding
eranda taila. Powders of other drugs are added and mixed well.
Composition/Constituents of Maharasnadi Kwatha:
MAHA RASNADI
KVATHA (AFI Part-I 4:28)
(Srngadharasamhita,
Madhymakhanda,)
|
Sl. No.
|
Sanskrit name
of drug
|
Latin name
|
Parts used
|
Quantity
|
|
1
|
Rasna
|
Pluchea lanceolata
|
(PI.)
|
50 parts
|
|
2
|
Dhanvayasa
|
Fagonia cretica
|
(PI.)
|
1 Part
|
|
3
|
Bala
|
Sida cordifolia
|
(PI.)
|
1 Part
|
|
4
|
Eranda-mula
|
Ricinus communis
|
(PI.)
|
1 Part
|
|
5
|
Devadaru
|
Cedrus deodara
|
(Ht.Wd.)
|
1 Part
|
|
6
|
Sathi (sati)
|
Hedychium spicatum
|
(Rz.)
|
1 Part
|
|
7
|
Vaca
|
Acorus calamnus
|
(Rz.)
|
1 Part
|
|
8
|
Vasaka (vasa)
|
Adhatoda vasika
|
(Rz.)
|
1 Part
|
|
9
|
Nagara (sunthi)
|
Zingiber officinale
|
(Rz.)
|
1 Part
|
|
10
|
Pathya (haritaki)
|
Terminalia chebula
|
(P.)
|
1 Part
|
|
11
|
Cavya
|
Piper retrofractum
|
(St.)
|
1 Part
|
|
12
|
Musta
|
Cyperus rotundus
|
(Rz.)
|
1 Part
|
|
13
|
Punarnava (rakta punarnava)
|
Boerhavia diffusa
|
(Rt.)
|
1 Part
|
|
14
|
Guduci
|
Tinospora cordifolia
|
(St.)
|
1 Part
|
|
15
|
Vrddhadaru
|
Argyreia nervosa
|
(Rt.)
|
1 Part
|
|
16
|
Satapuspa (Satahva)
|
Anethum sowa
|
(Fr.)
|
1 Part
|
|
17
|
Goksura
|
Tribulus terrestris
|
(Fr.)
|
1 Part
|
|
18
|
Asvagandha
|
Withania somnifera
|
(Rt.)
|
1 Part
|
|
19
|
Prativisa (ativisa)
|
Aconitum heterophyllum
|
(Rt.)
|
1 Part
|
|
20
|
Krtamala (aragvadha)
|
Cassia fistula
|
(Fr.P.)
|
1 Part
|
|
21
|
Satavari
|
Asparagus racemosus
|
(Rt. Tr.)
|
1 Part
|
|
22
|
Krsna (pippali)
|
Piper longum
|
(Fr.)
|
1 Part
|
|
23
|
Sahacara
|
Barleria prionitis
|
(Pl.)
|
1 Part
|
|
24
|
Dhanyaka
|
Coriandrum sativum
|
(Pl.)
|
1 Part
|
|
25
|
Kantakari
|
Solanum surattense
|
(Pl.)
|
1 Part
|
|
26
|
Brhati
|
Solanum indicum
|
(Pl.)
|
1 Part
|
Method of Preparation: Drugs are cleaned and
dried. They are coarsely powdered, weighted as per formula and then mixed well
and boiled with 16 times water and reduced up to 1/4th of total
quantity. After cooling the Sunthi curna (Zingiber
officinale); Pippali curna (Piper longum);
Ajamodadi curna; Eranda taila (Ricinus
communis oil) are added.
Composition/Constituents of Narayan Taila:
NARAYANA TAILA
(AFI Part-I 8:23)
(Bhaisajyaratanvali,
Vatavyadhyadhikara)
|
Sl. No.
|
Sanskrit name
of drug
|
Latin name
|
Parts used
|
Quantity
|
|
1
|
Bilva
|
Aegle marmelos
|
(Rt./St. Bk.)
|
480 g
|
|
2
|
Agnimantha
|
Premna mucronata
|
(Rt./St. Bk.)
|
480 g.
|
|
3
|
Syonaka
|
Oroxylum indicum
|
(Rt./St. Bk.)
|
480 g.
|
|
4
|
Patala
|
Stereospermum
suaveolens
|
(Rt./St./Bk.)
|
480 g.
|
|
5
|
Paribhadra
|
Erythrina
variegata
|
(St. Bk.)
|
480 g.
|
|
6
|
Prasarani
|
Paedaria foetida
|
(Pl.)
|
480 g.
|
|
7
|
Asvagandha
|
Witharia
somnifera
|
(Rt.)
|
480 g.
|
|
8
|
Brhati
|
Solanum indicum
|
(Pl.)
|
480 g
|
|
9
|
Kantakari
|
Solanum
surattense
|
(Pl.)
|
480 g.
|
|
10
|
Bala
|
Sida cordifolia
|
(Rt.)
|
480 g.
|
|
11
|
Atibala
|
Abutilon indicum
|
(Rt.)
|
480 g.
|
|
12
|
Svadamstra (goksura)
|
Tribulus
terrestis
|
(Pl.)
|
480 g
|
|
13
|
Punarnava (rakta Punarnava)
|
Boerhavia diffusa
|
(Rt.)
|
480 g
|
|
14
|
Water for decoction
|
|
|
49.152 l. Reduced to12.288 l.
|
|
15
|
Taila (tila)
|
Sesamum indicum
|
(Ol.)
|
3.072 kg
|
|
16
|
Satapuspa (satahva)
|
Anethum sowa
|
(Fr.)
|
96 g
|
|
17
|
Devadaru
|
Cedrus deodara
|
(Ht. Wd.)
|
96 g.
|
|
18
|
Mamsi (Jatamamsi)
|
Nordostachys
jatamansi
|
(Rz./Rt.)
|
96 g.
|
|
19
|
Saileyaka (saileya)
|
Parmelia perlata
|
(Pl.)
|
96 g.
|
|
20
|
Vaca
|
Acorus calamnus
|
(Rz.)
|
96 g.
|
|
21
|
Candana (rakta candana)
|
Pterocarpus
santalinus
|
(Ht. Wd.)
|
96g.
|
|
22
|
Tagara
|
Valeriana wallichi
|
(Rt./Rz.)
|
96 g.
|
|
23
|
Kustha
|
Saussurea lappa
|
(Rt.)
|
96 g.
|
|
24
|
Ela (suksmaila)
|
Elettaria
cardamomun
|
(Sd.)
|
96 g.
|
|
25
|
Salaparni
|
Desmodium
gangeticum
|
(Pl.)
|
96 g.
|
|
26
|
Prsniparni
|
Uraria picta
|
(Pl.)
|
96 g.
|
|
27
|
Mudgaparni
|
Vigna trilobata
|
(Pl.)
|
96 g.
|
|
28
|
Masaparni
|
Teramnus labialis
|
(Pl.)
|
96 g.
|
|
29
|
Rasna
|
Pluchea
lanceolata
|
(Rt./Lf.)
|
96 g.
|
|
30
|
Turagagandha (asvagandha)
|
Withania
somnifera
|
(Rt.)
|
96 g.
|
|
31
|
Saindhava lavana
|
Rock salt
|
|
96 g.
|
|
32
|
Punarnava (Rakta Purarnava)
|
Boerhavia diffusa
|
(Rt.)
|
96 g.
|
|
33
|
Satavararasa (satavari)
|
Asparagus
racemosus
|
(Rt. Tr.) .
|
3.072 l
|
|
34
|
Gavya ksira (go dugdha)
|
Cow milk
|
|
12.288 l.
|
Method of preparation:
All
the above drugs are mixed well and boiled on mild fire and stirred well
continuously to prevent the adherence of ingredients to the bottom of the
vessel. It is allowed to boil till the only oil remains.
Composition/Constituents
of Ksheerbala Taila Matra Basti:
KSIRABALA TAILA (AFI Part-I 8:11)
(Astangahrdaya, Vataraktacikitsa, Adhyaya)
|
Sl. No.
|
Sanskrit name of drug
|
Latin name
|
Parts used
|
Quantity
|
|
1
|
Bala kasaya
(bala decoction)
|
Sida cordifolia
|
(Rt.)
|
16 Parts
|
|
2
|
Bala kalka
(bala paste)
|
Sida cordifolia
|
(Rt.)
|
1 Part
|
|
3
|
Taila (tila)
|
Sesamum indicum
|
(Oil.)
|
4 Parts
|
|
4
|
Ksira
(godugdha)
|
Cow milk
|
|
4 Parts
|
|
5
|
Water
|
|
|
16 Parts
|
Method of
preparation:
All
the above drugs are mixed well and boiled on mild fire and stirred well
continuously to prevent the adherence of ingredients to the bottom of the
vessel. It is allowed to boil till the only oil remains.
Abbreviations used for parts of plants in the constituents(Alphabetical):
Exd. Exudate
Fr.P. fruit pulp
Ht. Wd. Heart Wood
Lf. Leaf
Ol. Oil
P. pericarp
Pl. Plant (Whole)
Rt. Tr Root Tuber
Rz. Rhizome
Rt. Root
St./Bk. Stem Bark
Abbreviations used for quantity :
g. gram
l. liter
English meaning of Sanskrit words used in formula:
Churna Powder
Kalka Paste
Kwatha Decoction
Taila Oil
|