To study the effectiveness of Haridra Dhooma Nasya(Turmeric Fume nasal inhalation) in Manyastambha(Cervical Spondylosis)

Phase 2/3

Not yet recruiting

Conditions: Spondylosis, unspecified. Ayurveda Condition: MANYASTAMBAH,

Registration Number: CTRI/2022/05/042457

Lead Sponsor: Parul Ayurved Hospital

Brief Summary: In India, the prevalence of *Manyastambha* is high because of Leading a sedentary lifestyle, sitting in front of a computer for long time, more bike riding, lack of neck exercise, improper sitting posture, increased mental stress, etc.In males the prevalence is 90% by age 50yrs, 96%in women older than 70yrs. 60- 70%women and 85% of men show changes related with cervical spondylosis by the age 45. In contemporary system of medicine cervical spondylosis is treated with NSAIDS, calcium supplements, Traction, surgical treatment. Long term use of such medication may cause harm to the liver and other vital organs. *Manyastambha* is one among the most common type of *Urdhvajatrugata Vata vyadhi* found in clinical practice. It is a disorder which is prevalent in the most active period of life. It was commonly seen in old age, but nowadays it is encountered in young and middle-aged people and can be compared to cervical spondylosis of contemporary science. As Dhooma *Nasya* is a type of *Nasya* according to Acharya *Charaka* but in todayâ€™s Panchakarma clinical practice, *Dhooma Nasya* is not being practiced and very less research work has been done till now. It is an ignored part of *Nasya* karma in Panchakarma. So, here it is an attempt to prove the efficacy of *Haridra Dhooma Nasya* mentioned in *Charaka* *Samhita* in the management of *Manyastambha*.

MATERIALS AND METHODS:

1. SOURCES OF DATA:

1. Literary source

All classical, modern literature and contemporary texts including the journals and internet sources about the disease, drug and procedures will be reviewed and documented for the study.

2. Clinical source

A minimum 30 cases of *Manyastambha*will be selected for the study from the IPD and OPD of Parul Ayurved Hospital.

2. Pharmaceutical Source

The drug will be prepared in GMP approved Pharmacy of Parul Institute of Ayurved

3. METHODS OF COLLECTION OF DATA

a. Study design:

It is an open clinical study with pre and post test assessment.

b. Sample size:   30

30 patients will be treated with*Haridra Dhooma Nasya.*

DIAGNOSTIC CRITERIA

The diagnosis is mainly based on clinical presentation of the patient according to signs & symptoms mentioned in classical ayurvedic texts, which are described under subjective & objective parameters.

1st -7th days: *Dhooma* *Nasya karma*scheduled

1st follow up on 8th day

2nd follow up on 15th day

Total study duration: 18 months

Assessment Criteria:

The patients will be observed during the treatment and then after the *parihara kala*and the change in the subjective sign and symptoms assessed by suitable scoring method and objective signs using appropriate clinical tools, Detail of which are given below

Subjective Criteria:

Symptoms of *Manyastambha*

1. *Manyashoola*(pain)

2. *Stambha*(stiffness)

3. *Gaurava*(Heaviness)

4. *Chimchimayana*(Numbness)

Objective criteria:

1. Flexion of neck Left & Right

2. Extension of neck

3. Rotation of neck

4. Flexion of neck

INVESTIGATIONS:

1. RBS

2. Urine-R & M

3. X-ray-Cervical Spine

INCLUSION CRITERIA:

1.      Patients having classical signs and symptoms of *Manyastambha.*

2.      Patients between age group of 18 to 60years.

3.      Patients of either gender irrespective of caste and religion.

4.      Patients fit for *Dhooma Nasya* *Karma*.

EXCLUSION CRITERIA:

1.      Subjects with uncontrolled metabolic disorders and other systemic disorders.

2.      Subject having any cardiac complaints will be excluded.

3.      H/o Fracture and dislocations of Neck.

4.      H/o Injury to spinal nerves or spinal cord.

5.      Involvement of debilitating neurological condition such as Paralysis, brachial palsy,etc

6.      Subjects contraindicated for *Nasya* *karma*.

INTERVENTION:

| | | | | | |

| --- | --- | --- | --- | --- | --- |

|FORMULATION

TIME OF             PROCEDURE

DOSE

DURATION

PROCEDURE

SAMPLE SIZE

|*HARIDRA DHOOMA NASYA*

Morning and Evening

3 PUFFS in each nostril.

7 DAYS

*DHOOMA NASYA*

30

       ASSCESSMENT OF DHOOMA NASYA KARMA:

| | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- |

|*Lakshana*

Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Day 7

|*Hrudaya* *sudhi*



|*Kantah* *sudhi*



|*Mukha* *sudhi*



|*Nasa* *sudhi*



|*Shira* *laghavata*

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1.Patients having classical signs and symptoms of Manyastambha.
2.Patients between age group of 18 to 60years.
4.Patients fit for Dhooma Nasya Karma.

Exclusion Criteria

1.Subjects with uncontrolled metabolic disorders and other systemic disorders.
2.Subject having any cardiac complaints will be excluded.
3.H/o Fracture and dislocations of Neck.
4.H/o Injury to spinal nerves or spinal cord.
5.Involvement of debilitating neurological condition such as Paralysis, brachial palsy.etc 6.Subjects contraindicated for Nasya karma.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Helps in Reducing pain, stiffness, heaviness and numbness in cervical region.	On 8th Day

Secondary Outcome Measures

Name	Time	Method
Improvement in range of movement of Neck.	on 15th Day

Trial Locations

Locations (1): Parul Ayurved Hospital
🇮🇳
Vadodara, GUJARAT, India
Parul Ayurved Hospital
🇮🇳Vadodara, GUJARAT, India
Gaurav Kumar Dash
Principal investigator
8908499504
1dash.gaurav@gmail.com