To Evolve An Ayurvedic Medicine For The Management Of Neck Pain

Phase 2

Not yet recruiting

Conditions: Other spondylosis. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAM (KEVALAVATA),

Registration Number: CTRI/2025/04/084673

Lead Sponsor: State Ayurvedic College And Hospital, Lucknow

Brief Summary: The Present Synopsis Entitled "A Clinical Study To Evolve An Ayurvedic Regimen For The Management Of Greevastambha w.s.r. To Cervical Spondylosis".

AIM OF STUDY - To establish the efficacy of Haritakyadi Guggulu, Katu Tail Abhayanga, Ashwagandha Churna Kalka Lepa and Pippali Saindhava nasya as a regimen in cases of Greevastambha w.s.r. to Cervical Spondylosis.

OBJECTIVE -

PRIMARY OBJECTIVES: To establish an Ayurvedic regimen for the management of greevastambha.

SECONDARY OBJECTIVES:

1. To assess the role of increased load of sedentary lifestyle in increased prevalence rate.

2. To assess the reduction in the need of NSAIDs and steroids in the patients of cervical spondylosis.

PLAN OF STUDY

SCREENING OF INDIVIDUALS

1. For the purpose of clinical trial, the patients of greevastambha/cervical spondylosis will be selected irrespective of caste, sex and religion fulfilling the essential criteria will be selected randomly from O.P.D at state ayurvedic college and hospital, Lucknow and also the referred cases which fulfil the criteria.

2. A careful history, physical examination and necessary investigation will be performed as Performa prepared for the present trial.

TYPE OF STUDY- Single armed, open label, Phase-2

SAMPLE SIZE- Minimum 60 patient of Cervical Spondylosis from OPD of State Ayurvedic College, Lucknow and other referred patients will be selected according to the Inclusion and Exclusion criteria with approximately 10% drop out.

n = Z2PQ/e2

INCLUSION CRITERIA

1. Patient of the age group between 25-65 years will be selected irrespective of sex, caste and religion.

2. All socio-economic person.

3. Patient voluntarily willing to sign the consent form for the clinical trial.

4.Patient of greevastambha with or without non-essential criteria.

EXCLUSION CRITERIA

1. Patient not from the age group mentioned in the inclusion criteria.

2. Patients with extra cervical ribs.

3. Patients with injury to cervical spine.

4. Patients with diabetes Mellitus, Thyroid disorder and Hypertension.

5. Gouty and Rheumatoid arthritis.

6. Patients having complication of cervical spondylosis or permanent impairment and associated diseases.

7. Patients of torticollis.

8. Patients of ankylosing Spondylosis.

9. Patients with endocrine disorders and genetic locomotory disorders.

10. Patients having any other systemic disorders.

11. Pregnant and Lactating women.

CRITERIA FOR WITHDRAWL

1. Subjects not willing to continue.

2. If patient develops any other acute illness during trial period which may hinder the study.

3. If patient develops any adverse effect or aggravation of complains.

4. The condition of the patient deteriorates during the trial.

5. Personal matters.

GROUPING OF PATIENTS

There will be a single group of 60 patients with 10% drop out.

DOSE AND DURATION

1. Haritakyadi guggulu will be prescribed 2 tablets of 375mg each (one tablet of 3 ratti) twice a day (BD) after meal to the patient with lukewarm water for 2 months.

2. Mridu Abhyanga with lukewarm Katu tail for the duration of 15 minutes once a day in the morning will be advised for the period of 2 months.

3. Freshly prepared Ashwagandha churna kalka lepa of thickness 0.48cm (1/4th angul) will be applied over the neck area and immediately removed when the lepa dries after the massage in the morning for the period of 2 months.

4. Classical Nasya of Pippali Saindhava (avpeeda nasya) will be given for seven days in the morning in heena/ madhyam/ uttama matra according to rog and rogi bala in each month.

PERIOD OF STUDY

Duration of Clinical trial will be of 60 days with follow up period of 15 days i.e. every fortnight.

FOLLOW UP PERIOD

FOLLOW UP PERIOD WITH DRUG- Registered patients will be followed up every fortnight for 2 months i.e. D0, D15, D30, D45, D60.

FOLLOW UP PERIOD WITHOUT DRUG- Once after the period of 15 days i.e.D75. TOTAL DURATION OF CLINICAL TRIAL- 75 Days

CRITERIA FOR ASSESSMENT

Data will be collected before, during and after completion of trial and will be subjective for analysis.

All the essential and non-essential criteria will be graded 0, 1, 2, 3 on the basis of its intensity & severity given by persons on complained & confirmed by clinical examination during the trial.

ESSENTIAL CRITERIA

1. Greeva shoola (neck pain).

2. Greeva stambha (neck stiffness).

3. Greeva hundana (restricted movements of neck).

NON-ESSENTIAL CRITERIA

1. Gatrasuptata (paresthesia).

2. Paniprishtashirogreha (radiation of pain to the back of head, shoulders and arms).

3. Anidra (Sleep disturbances)

4. Vertigo

Radiological assessment

X-ray findings of cervical spondylosis (AP and Lateral view)

All the registered patients will be assessed radiologically before and after trial for the differential diagnosis and radiological changes if any.

ASSESSMENT OF RESULT

The total effect of therapy of this trial will be grouped as follow-

Marked improvement

Moderate Improvement

Mild Improvement

Unchanged

Worsened

1. Marked improvement

Patient having >75% relief in terms of clinical symptoms.

No recurrence of clinical symptoms up to follow up period.

2. Moderate Improvement

Patient having 51-75% relief in terms of clinical symptoms.

Moderate recurrence of clinical symptoms up to follow up period.

3. Mild Improvement

Patient having 25-50% relief in terms of clinical symptoms.

Mild recurrence of clinical symptoms up to follow up period.

4. Unchanged

Patient having <25% relief in terms of clinical symptoms.

Disease may reoccur.

5. Worsened

Patient having increase in presenting clinical symptoms.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patient of the age group between 25-65 years will be selected irrespective of sex, caste and religion.
All socio-economic person.
Patient voluntarily willing to sign the consent form for the clinical trial.
Patient of greevastambha with or without non-essential criteria.

Exclusion Criteria

Patient not from the age group mentioned in the inclusion criteria.
Patients with extra cervical ribs.
Patients with injury to cervical spine.
Patients with diabetes Mellitus, Thyroid disorder and Hypertension.
Gouty and Rheumatoid arthritis.
Patients having complication of cervical spondylosis or permanent impairment and associated diseases.
Patients of torticollis.
Patients of Ankylosing Spondylosis.
Patients having any other systemic disorders.
Pregnant and Lactating women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Greeva shool (Neck pain)	Before trial, 15th day, 30th day, 45th day, 60th day, after trial
Greeva stambha (Neck stiffness)	Before trial, 15th day, 30th day, 45th day, 60th day, after trial
Greeva hundana (Restricted movement of the neck)	Before trial, 15th day, 30th day, 45th day, 60th day, after trial

Secondary Outcome Measures

Name	Time	Method
Gatrasuptata (paresthesia)	paniprishtashirogreha (radiation of pain to the back of head, shoulders and arms)

Trial Locations

Locations (1): State Ayurvedic College And Hospital, Lucknow
🇮🇳
Lucknow, UTTAR PRADESH, India
State Ayurvedic College And Hospital, Lucknow
🇮🇳Lucknow, UTTAR PRADESH, India
Dr Vaishali Sagar
Principal investigator
9650799049
sagar.vaishali96@gmail.com