Scientific validation of the efficacy and safety of a Proprietary Ayurvedic Combination in

the treatment of VATA (Inflammatory Musculoskeletal) disorders

Upadhyay AK*, BAMS, PGDCR, Ph.D. (Pur. Ayu. Oriental Medicine) Senior Consultant,
National Institute of Health Education & Awareness, Haridwar, India. Sahu NM, BAMS,
Technical Expert, Patanjali Ayurved Limited, Haridwar, India. Mishra S, B. Tech (Bio-tech),
M.Sc. (Bio-tech), Patanjali Bio-Research Institute, Haridwar, India
[*Corresponding author]
Abstract
Vata disorders (Inflammatory Musculoskeletal Disorders) are the leading causes of morbidity
and work absenteeism and recent clinical studies have proved the benefits of topical formulations
like taila (Medicated Oil), ghrit (Medicated Ghee), lep (Medicated Ointment/ Cream/
Lotion/Gel) etc. along with internally taken medicine in management of these vata related
conditions. This study was planned to evaluate the efficacy and safety of SHOOL SANGHAR
OIL & TABLETS a Proprietary Ayurvedic Combination in the management of sciatica, arthritis
and other inflammatory musculoskeletal disorders.
This study was an open, prospective, non-comparative, clinical evaluation. Twenty two patients,
of either sex, with various symptoms of either of sciatica or arthritis, or inflammatory
musculoskeletal disorders were included for the safety and efficacy evaluation of Proprietary
Ayurvedic Combination. All the patients were advised to apply the oil over the affected area, and
take one tablet thrice daily for a period of 2 weeks, the patients were followed up for 2 weeks
and symptomatic evaluation was recorded after completion of each week. A complete clinical
and joint evaluation was carried out at the end of the 2nd week. The predefined primary outcome
measures for efficacy were improvement in the symptoms and signs, and the secondary safety
endpoints were safety assessed by incidence of adverse events and patient compliance to therapy.
All the adverse events reported or observed by patients were recorded with information about
severity, date of onset, duration and action taken regarding the Proprietary Ayurvedic
Combination.
This study observed a significant improvement in of sciatica, arthritis and other inflammatory
musculoskeletal disorders, after a weeks therapy, and all the patients experienced complete relief
at the end of 2 weeks of treatment. Also, there were no clinically significant adverse reactions,
and the overall compliance to the therapy was excellent. These beneficial clinical effects might
have been due to the synergistic activities of the ingredients of Proprietary Ayurvedic
Combination. Therefore, it may be concluded that SHOOL SANGHAR OIL & TABLETS are
effective and safe in the management of sciatica, arthritis and other inflammatory
musculoskeletal disorders.
Keywords: Vata disorders, Sciatica, Inflammatory Musculoskeletal Disorders, Pain Oil,
Ayurvedic Preparation

Introduction
Arthritis and conditions like frozen shoulder, synovitis and sprains have their correlates in
Ayurvedic system of medicine as amavata,1 sandhigata vata,2 asthigata vata, 3 mamsagata vata, 4
shotha,5 shoola,6 gridhrasi7 etc. Application of medicated oils (bahya snehana) followed by
hot fomentation (swedana)8 along with some internal medication is among the general
procedures recommended in Ayurveda for the management of above mentioned conditions to
reduce pain, stiffness, swelling9 etc. The studies show that ingredients of these medicated oils
and vati (tablets) possess analgesic and anti-inflammatory properties.10 These oils are, therefore,
likely to be effective in reducing pain and inflammation, and normalizing the performance of
affected structures. In Allopathic system of medicine non-steroidal anti inflammatory drugs
(NSAIDs) are used for management of these conditions despite of their associated risk of
gastrointestinal,11 renal12 and cardiovascular13 complications. External application along internal
medication are generally considered as safe, as the adverse effects are mainly limited to the
site of application and systemic adverse effects are rare. 14
Each 10ml of polyherbal oil has Shudh Kuchla (Strychnos nux-vomica) 200 mg, Shudh Dhatura
Panchang (Datura stramonium) 200 mg, Shudh Vatsnabh (Aconitum
ferox)
200
mg,
Ashwagandha (Withania somnifera) 150 mg, Kalaunji (Nigella sativa) 150 mg, Kayphal (Myrica
esculenta) 200 mg, Patang (Caesalpinia sappan) 200 mg, Saunth (Zingiber officinale) 200 mg,
Amahaldi (Curcuma amada) 200 mg, Nimb Chhal (Azadiracta indica) 100 mg, Nirgundi Beej
(Vitex negundo) 100 mg, Laung Tail (Syzigium aromaticum) 1 ml, Tarpin Tail (Pinus Oil) 0.4 ml,
Pudina Tail (Mentha pipreta) 0.25 ml, Kapoor (Cinnamomum camphora) 0.25 mg, Nilgiri Tail
(Eucalyptus globules) 0.25 ml, Sat Ajwain (Trachyspermum ammi) 0.25 gm, Gultharia Tail
(Gaultheria fragrantissima) 0.25 ml, Linseed Oil (Linum usitatissimum) 0.25 ml, Til Tail
(Sesamum indicum) 8 ml and approved added colours / perfumes as ingredients. Each 500 mg of
polyherbal tablets has Saunth (Zingiber officinale) 50 mg, Rasna (Pluchea lanceolata) 50 mg,
Gandhprasarini (Paederia foetida) 40 mg, Nirgundi (Vitex negundo) 50 mg, Shallaki (Boswellia
serrata) 40 mg, Chandrashoor (Lapidium sativum) 40 mg, Suranjan (Colchicum luteum) 40 mg,
Vacha (Smilax glabra) 40 mg, Shudh Kuchla (Strychnos nux-vomica) 40 mg, Harad (Terminalia
chebula) 100 mg and approved preservative as ingredients.
Musculoskeletal disorders are the leading causes of morbidity and work absenteeism. Despite the
associated risk of gastrointestinal,15 renal16 and cardiovascular complications 17 conventionally,
systemic NSAIDs are preferred for the management of muscle strains and musculoskeletal
disorders. Recently, some clinical studies have proved the benefits of topical analgesics in the
management of painful inflammatory musculoskeletal conditions. 17 Topical analgesics with
counterirritants are especially useful in the symptomatic management of arthritis and
neuropathies. 18

Aim of the study

The present study was aimed to evaluate the clinical efficacy and safety of SHOOL SANGHAR
OIL & TABLETS in the management of sciatica, arthritis and other inflammatory
musculoskeletal disorders.
Study design
This study was an open, prospective, non-comparative clinical evaluation and was conducted at
R&D Centre, Rashtriya Swasthya Shiksha Avam Jagrukta Sansthan, Kankhal under association
with technical experts of Patanjali Ayurved Limited, Padartha, Laksar Road, Haridwar
(Uttarakhand).
Materials and methods
Inclusion criteria
A total of 22 patients, of either sex, with clinical symptoms of either of arthritis, sciatica or
inflammatory musculoskeletal disorders, and who were seen as out patients were enrolled in the
study. A written informed consent was obtained from all the patients.
Exclusion criteria
Patients with established renal, hepatic or cardiac failure, patients on long-term steroid treatment,
patients suffering from any autoimmune disorder, spastic condition or genetic disorder were
excluded from the study.
Study procedure
A detailed medical history of all the patients was recorded and symptomatic evaluation was
done. The diagnosis of the concerned disease was confirmed by clinical and joint
examination. All the patients were advised to apply the SHOOL SANGHAR OIL over the
affected area, and take one tablet of SHOOL SANGHAR TABLET thrice daily after breakfast
and meals for a period of 2 weeks.
Follow-up and assessment
The patients were followed up for 2 weeks and symptomatic evaluation was recorded after the
completion of each week. A complete clinical and joint evaluation was carried out at the end of
the 2nd week.
Primary and secondary outcome measures
The predefined primary outcome measures for efficacy were improvement in the symptoms and
signs of arthritis, sciatica and inflammatory musculoskeletal disorders. Secondary safety

endpoints were safety assessed by the incidence of adverse events and patient compliance to
therapy.
Adverse events
All the adverse events either reported or observed by patients were recorded with information
about severity, date of onset, duration and action taken regarding the study drug.
Analysis
Analysis was done according to intent-to-treat principles. Changes in various parameters from
baseline values after the each week were evaluated on the basis of severe, moderate, mild and
None basis giving them a maximum point of 10 for severe conditions.
Results
A total of 22 (9 males and 13 females) patients were included in the study, and the mean age was
40.32 years (SD=11.06). There was a highly significant improvement in sandhi shool (joint
pain), Shoth (inflammation), sparsahyata (joint tenderness), joint stiffness and range of
movement, after a weeks therapy, and all the patients experienced complete relief at the end of
2 weeks of treatment (Table 1 and Figure 1). There were no clinically significant adverse
reactions, either reported by the patients.
Table 1: Changes in various signs and symptoms after treatment with Proprietary
Ayurvedic Combination.
Parameters
Baseline
After 1 week
After 2 weeks
Sandhishool (Joint Pain) Mean SD
Mean SD
Shoth (Inflammation)

6.32 0.48

4.14 0.83

1.86 0.77

4.64 0.49

3.36 0.95

1.36 0.49

Sparsahyata (Tenderness) Mean SD

Mean SD
Stiffness

4.27 1.28

3.41 0.50

1.32 1.13

3.68 0.48

2.73 0.46

1.00 0.00

Difficulty in Movement Mean SD

4.05 0.84

2.91 0.87

0.36 0.49

Sandhishool (Joint Pain)

6.32
4.14
1.86

W
ee
ks

1.36

7.00
6.00
5.00
4.00
3.00
2.00
1.00
0.00

Af
te
r2

3.36

W
ee
k

4.64

Af
te
r1

5.00
4.00
3.00
2.00
1.00
0.00

Ba
se
lin
e

Shoth (Inflammation)

Stiffness in Joints
4.00
3.00
2.00
1.00
0.00

Sparsahyata (Tenderness)

3.68
2.73
1.00

Difficulty in Movement
5.00
4.00
3.00
2.00
1.00
0.00

4.05

2.91
0.36

5.00
4.00
3.00
2.00
1.00
0.00

4.27

3.41
1.32

Figure 1: Changes in various signs and symptoms after treatment with Proprietary
Ayurvedic Combination.

Discussion
Inflammatory musculoskeletal disorders lead to a compromised quality of life. Chronic, mild,
intermittent joint pain and joint swelling are the cardinal features of these disorders. Recent
studies have shown that damage to a peripheral nerve results in the reduced blood supply to
myelinated fibers, which leads to demyelination, and produce ectopic impulses that are perceived
as the sharp, shooting, or burning pain.19
This study observed a highly significant improvement in muscular pain, joint swelling, joint
tenderness, joint stiffness and range of movement, after a weeks therapy, and all the patients
experienced complete relief at the end of 2 weeks of treatment. Also, there were no clinically
significant adverse reactions, and the overall compliance to the therapy was excellent. These
beneficial clinical effects might have been due to the synergistic activities of the ingredients of
SHOOL SANGHAR OIL & TABLETS, which are well documented.
CONCLUSION
Sciatica, arthritis and other inflammatory musculoskeletal disorders are the leading causes of
morbidity and work absenteeism. Recent clinical studies have proved the benefits of topical
formulations along with internal medications in the management of certain acute and chronic
painful inflammatory musculoskeletal conditions. This study was planned to evaluate the
efficacy and safety of SHOOL SANGHAR OIL & TABLETS in the management of sciatica,
arthritis and other inflammatory musculoskeletal disorders.
This study observed a highly significant improvement in joint pain, joint swelling, joint
tenderness, joint stiffness and range of movement, after a weeks therapy, and all the patients
experienced complete relief at the end of 2 weeks treatment. Also, there were no clinically
significant adverse reactions, and the overall compliance to the therapy was excellent. These
beneficial clinical effects might have been due to the synergistic activities of the ingredients of
SHOOL SANGHAR OIL & TABLETS. Therefore, it may be concluded that SHOOL
SANGHAR OIL & TABLETS is effective and safe in the management of sciatica, arthritis and
other inflammatory musculoskeletal disorders.
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