“Role and effect of ayurvedic intervention in the management of Sandhigata Vata of Kati (Lumbar spondylosis)â€

Phase 2

Not yet recruiting

• Conditions: Other spondylosis,

• Registration Number: CTRI/2020/10/028631
• Lead Sponsor: Central Council for Reasearch in Ayurvedic Sciences

Brief Summary

*Sandhigatavata*is mentioned under*Vata Vyadhi.Acharya Charaka* has mentioned that*Nidan Sewana*aggravates*Vata*andthis Vitiated *Vata*gets accumulated in *Rikta Srotasa* togives rise various generalized and localized diseases. In case,*Vata*isvitiated in *Kati Pradesh*that leads to*KatisandhigataVata.*The symptomatology of*Sandhigata Vata*are *HantiSandhigataha*(loss of function),*Shoola*(Pain),*Aatopah*(Swelling),*Vatapoorna  Driti Sparshah (*Feelings of air filledin joints),*Shotha*(Inflammatory conditions)*, PrasaaranaAakunachana Sah Vedanaa*(Pian on flexion &  extention). Incontemporary medical science, the similar condition of Lumbar Spine isexplained as Lumbar Spondylosis.

**Aims andObjectives:**

1.     To assess the efficacy ofAyurvedic intervention in the management of *Sandhigatavata*of*Kati*

2.     To compare the effect ofAyurvedic intervention with the control group in the management of *Sandhigatavata*of*Kati*

3.     To study thepathophysiology of*Sandhigatavata*of*Kati*

**ADMINISTRATION OF DRUG:**100clinically diagnosed and registered patients of *‘Sandhigatavata ofKati’*(Lumbar Spondylosis)will be divided randomlyinto two groups. 50 patients will be included in each group. GroupA: Patients will be administered controlled group Methylcobalamine(750mcg) pregabaline (75mg) – 1 Once daily for 3 months , Diclofenac 100mg – 1Once daily for 15 days then SOS basis, Methyl prednisolone – 8mg for first5days then 4 mg next 5 days then 4 mg alternate days orally for 15 days. GroupB: *BahyaSnehana, Swedana* and *Basti Karma*for15 days/monthalong with the trialdrug “*RasnadashmooladiKwathaâ€*40ml twice a day before meal orally for 3 month.

**Inclusion criteria-**

1.     Patients willing for trial and giveconsent.

2.     Patients of age group 30 to 60 years ofeither sex.

3.     Patients having signs and symptomsof *Sandhigatavata of Kati* (lumbar spondylosis) as mentionedin *Ayurvedic* and Modern texts.

**Exclusion criteria**

1.     Patients not willing for trial.

2.     Age below 30 and above 60 years ofeither sex.

3.     Patients having serious accidentalinjuries involving structural deformity.

4.     Patients with Potts spine, spinal andparavertebral tumors.

5.     Patients with fractures, kyphosis,scoliosis, osteoporosis

6.     Patients with rectal or vaginalprolapsed, metastatic and uterine conditions.

7.     Pregnant and lactating women.

8.     Patients suffering from serioussystemic disorders like renal diseases, heart diseases, malignant hypertention,diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-10-23
• Study Start: 2020-10-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Patients willing for trial and give consent.
• 2.Patients of age group 30 to 60 years of either sex.
• 3.Patients having signs and symptoms of Sandhigatavata of Kati (lumbar spondylosis) as mentioned in Ayurvedic and Modern texts.

Exclusion Criteria

• 1.Patients not willing for trial.
• 2.Age below 30 and above 60 years of either sex.
• 3.Patients having serious accidental injuries involving structural deformity.
• 4.Patients with Potts spine, spinal and paravertebral tumors.
• 5.Patients with fractures, kyphosis, scoliosis, osteoporosis 6.Patients with rectal or vaginal prolapsed, metastatic and uterine conditions.
• 7.Pregnant and lactating women.
• 8.Patients suffering from serious systemic disorders like renal diseases, heart diseases, malignant hypertention, diabetes mellitus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients of both sexes between age group 30-60	3 months
signs and symptoms	3 months
of Sandhigata Vata of Kati Pradesh will be selected for relieving	3 months

Secondary Outcome Measures

Name	Time	Method
Assess the comparative efficacy between	Ayurvedic intervention and Control group after 3

Trial Locations

Locations (1)

Banaras Hindu University; 🇮🇳 Varanasi, UTTAR PRADESH, India

Banaras Hindu University

🇮🇳Varanasi, UTTAR PRADESH, India

Dr Niharika Shakya

Principal investigator

9024025873

nshakya07089@gmail.com