CTRI

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CTRI Number

CTRI/2025/04/084673 [Registered on: 13/04/2025] Trial Registered Prospectively

Last Modified On:

04/04/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Single Arm Study

Public Title of Study

To Evolve An Ayurvedic Medicine For The Management Of Neck Pain

Scientific Title of Study

A Clinical Study To Evolve An Ayurvedic Regimen For The Management Of Greevastambha wsr To Cervical Spondylosis

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Vaishali Sagar
Designation	Research Scholar
Affiliation	State Ayurvedic College And Hospital, Lucknow
Address	Post Graduate Department of Kayachikitsa, State Ayurvedic College And Hospital, Tulsidas Marg, Turiyaganj Lucknow, 226004 Uttar Pradesh, India Lucknow UTTAR PRADESH 226004 India
Phone	9650799049
Fax
Email	sagar.vaishali96@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Shachi Srivastava
Designation	Associate Professor
Affiliation	State Ayurvedic College And Hospital, Lucknow
Address	Post Graduate Department of Kayachikitsa, State Ayurvedic College And Hospital, Tulsidas Marg, Turiyaganj Lucknow, 226004 Uttar Pradesh, India Lucknow UTTAR PRADESH 226004 India
Phone	9415063998
Fax
Email	drshachi09@gmail.com

Details of Contact Person
Public Query

Name	Vaishali Sagar
Designation	Research Scholar
Affiliation	State Ayurvedic College And Hospital, Lucknow
Address	Post Graduate Department of Kayachikitsa, State Ayurvedic College And Hospital, Tulsidas Marg, Turiyaganj Lucknow, 226004 Uttar Pradesh, India Lucknow UTTAR PRADESH 226004 India
Phone	09650799049
Fax
Email	sagar.vaishali96@gmail.com

Source of Monetary or Material Support

Post Graduate Department of Kayachikitsa, State Ayurvedic College And Hospital, Tulsidas Marg ,Turiyaganj Lucknow, 226004 Uttar Pradesh, India

Primary Sponsor

Name	State Ayurvedic College And Hospital, Lucknow
Address	Post Graduate Department of Kayachikitsa, State Ayurvedic College And Hospital, Tulsidas Marg ,Turiyaganj Lucknow, 226004 Uttar Pradesh, India
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Vaishali Sagar	State Ayurvedic College And Hospital, Lucknow	Post Graduate Department of Kayachikitsa, Room no. 25, State Ayurvedic College And Hospital, Tulsidas Marg, Turiyaganj, Lucknow, 226004 Uttar Pradesh, India Lucknow UTTAR PRADESH	9650799049 sagar.vaishali96@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
SAC Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:M478\|\|Other spondylosis. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAM (KEVALAVATA),

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: HARITAKAYADI GUGGULU , Reference: Brihut Nighantu Ratnakar, aamvaatkarmavipaka Adhyaya, Route: Oral, Dosage Form: Guggulu , Dose: 750(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: -Along with medicine, following procedures are included ASHWAGANDHA CHURNA KALKA LEPA, KATU TAIL ABHYANGA and PIPPALI SAINDHAVA NASYA

Inclusion Criteria

Age From	25.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	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.

ExclusionCriteria

Details

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 with endocrine disorders and genetic locomotory disorders.
Patients having any other systemic disorders.
Pregnant and Lactating women.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

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

Secondary Outcome

Outcome	TimePoints
Gatrasuptata (paresthesia) paniprishtashirogreha (radiation of pain to the back of head, shoulders and arms) Anidra (Sleep disturbances) Vertigo	Before trial, 15th day, 30th day, 45th day, 60th day, after trial

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 2

Date of First Enrollment (India)

01/05/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

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.