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

Completed

• Conditions: Bilateral primary osteoarthritis of knee, Osteoarthritis Knee (Sandhivata),

• Registration Number: CTRI/2013/12/004241
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary

This is an open label interventional study for evaluating the safety andefficacy of classical ayurvedic therapeutic regimen consisting of Vatariguggulu 500mg 2 tab thrice a day, Maharasnadi kwatha 20ml twice a day, localapplication of Narayan taila for 12 weeks along with the ksheer bala taila 60mlMatra Basti Chikitsa in threecourses of nine days each (from Day 1st to 9th & 30thto 38th & 60th to 68th day)  in 60 patients with Osteo-arthritis Knee. Thetrial will be conducted in Ayurveda Mental Health Research Institute, Nagpur,India. In this proposed study the effect of this combination will be evaluatedfor clinical response and change in the quality of life by using standardparameters. The primary outcome measures will be Change in WOMAC total score. The secondary outcomes will be Change in WOMAC stiffness Domain Score, Change inWOMAC Physical function Domain, Global assessment of disease activity, Changein the visual analogue scale (VAS) for pain in last 48 hrs. and at the end of 14th day, 28th day, 42ndday, 56th day, and 70th day and 84th day andafter 4 weeks of follow-up study. The Assessment of change in Ayurvedicdisease 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 addingeranda taila. Powders of other drugs are added and mixed well.

**Composition/Constituents of Maharasnadi Kwatha:**

**MAHA RASNADIKVATHA (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 anddried. They are coarsely powdered, weighted as per formula and then mixed welland boiled with 16 times water and reduced up to 1/4th of totalquantity. After cooling the Sunthi curna (*Zingiberofficinale*); Pippali curna (*Piper longum)*;Ajamodadi curna; Eranda taila (*Ricinuscommunis* 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:**

Allthe above drugs are mixed well and boiled on mild fire and stirred wellcontinuously to prevent the adherence of ingredients to the bottom of thevessel. It is allowed to boil till the only oil remains.

**Composition/Constituentsof 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 ofpreparation:**

Allthe above drugs are mixed well and boiled on mild fire and stirred wellcontinuously to prevent the adherence of ingredients to the bottom of thevessel. 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-11
• Study Completion: 2015-09-03
• Last Update Posted: 2019-11-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Change in WOMAC stiffness Domain Score

Trial Locations

Locations (1)

Ayurveda Mental Health Research Institute; 🇮🇳 Nagpur, MAHARASHTRA, India

Ayurveda Mental Health Research Institute

🇮🇳Nagpur, MAHARASHTRA, India

Dr Savita Sharma RO Ay PI

Principal investigator

9422823964

savitashirish@yahoo.co.in