A clinical study to check effect of two drugs bruhatlashunpinda and rasnasaptak kwatha on patients with manyastambha with special reference to cervical spondylosis.

Phase 2/3

Not yet recruiting

• Conditions: Other spondylosis with myelopathy. Ayurveda Condition: MANYASTAMBAH,

• Registration Number: CTRI/2022/08/044780
• Lead Sponsor: Dr Prachi Patwari

Brief Summary

**TITLE OF DISSERTATION**

 RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE EFFICACY OF BRUHATLASHUNPINDA AND RASNASAPTAK KWATHA IN THE MANAGEMENT OF MANYASTAMBHA WITH SPECIAL REFERENCE TO CERVICAL SPONDYLOSIS.

**AIMS AND OBJECTIVES**

**AIMS-**

To study and compare the effect of Bruhatalashunapinda and Rasnasaptak kwatha in the management of Manyastambha with special reference to Cervical spondylosis.

 **OBJECTIVES-**

1) To evaluate efficacy of Bruhatalashunapinda in the management of Manyastambha with special reference to cervical spondylosis.

3) To evaluate efficacy of Rasnasaptak kwatha in the management of Manyastambha with special reference to cervical spondylosis.

2) To study Manyastambha in detail according to Ayurved Samhita and cervical spondylosis according to modern view.

**HYPOTHESIS**

**NULL HYPOTHESIS-**

Effect of Bruhatalashunapinda is not significant than Rasnasaptak kwatha in the management of Manystambha with special reference to cervical spondylosis.

 **ALTERNATE HYPOTHESIS-**

Effect of Bruhatalashunapinda is significant than Rasnasaptak kwatha in the management of Manystambha with special reference to cervical spondylosis.

**RESEARCH QUESTION**

**PRIMARY RESEARCH QUESTION**

Is there any significant difference between Bruhatlashunpinda and Rasnasaptak kwatha in the management of Manyastambha with special reference to Cervical spondylosis?

**SECONDARY RESEARCH QUESTION**

Is Bruhatlashunpinda is effective in the management of Manyastambha with special reference to Cervical spondylosis?

**METHOD OF COLLECTION OF DATA**

Considering 20% Dropout rate, we propose to enroll 72 subjects (36 in each group) to get 60 evaluable cases (30 in each group) at the end of the study. These subjects will be fulfilling inclusion Criteria, which will be selected from D.Y. Patil Ayurvedic Hospital Nerul Navi Mumbai OPD No.1 and IPD (Kayachikitsa department) and randomly divided into two groups –Group A and B. Group A subjects will be treated with Bruhatalashunapinda and Rasnasaptak Kwatha and Group B Subjects will be treated with Rasnasaptak Kwatha  (Control group) for 28 days. levels of improvement will be recorded in three visits v1,v2,v3. Each visit will be 7 days apart.

**DIAGNOSTIC CRITERIA**

1)          Pain (Ruja)

2)          Stiffness (Stambha)

3)          Restricted neck movements.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-07-21
• Study Start: 2022-08-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Well diagnosed patients of manyastambha (Cervical spondylosis).
• 2.Subjects having neck pain with or without radicular symptoms paresthesia since more than two months.
• 3.Cervical spondylitis confirmed by radiological assessment (X ray cervical vertebrae AP and lateral view.
• 4.Subjects were willing to give informed consent and ready to comply with the protocol.
• 5.Subjects who are ready to provide regular follow ups till completion of the study.

Exclusion Criteria

• 1.Known cases of trauma of neck, local wound and infection over neck, cervical rib syndrome, any spinal cord disorders other than cervical spondylosis & myelopathy.
• 2.Known cases of shoulder and elbow musculoskeletal problems, fracture of spine and upper limb.
• 3.Known cases of inflammatory arthritis.
• 4.Subjects who use any other investigational drug within one month prior to randomization.
• 5.Known cases of Tuberculosis, HIV, Ischemic heart disease, Cancer.
• 6.Known cases of Hypertension, Hyperacidity, Peptic ulcer, Duodenal ulcer.
• 7.Pregnancy and Lactation.
• 8.Other conditions, which in the opinion of investigators, makes the patient unsuitable for enrollment or could interfere with his/her participation in, and completion of the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Visual Analog Scale, Neck Disability Index, Goniometry readings and neck pain, stiffness, restricted neck movements.	4 weeks

Trial Locations

Locations (1)

D. Y. Patil School of Ayurveda; 🇮🇳 Thane, MAHARASHTRA, India

D. Y. Patil School of Ayurveda

🇮🇳Thane, MAHARASHTRA, India

Dr Prachi Dhananjay Patwari

Principal investigator

9028191514

prachidk10@gmail.com