A clinical trial to study the efficacy of Dashmool Grhit nasal drops & Pathyadi Kwath as syrup for oral intake in themanagement of Ardhavbhedhak in general known as Migraine

Not yet recruiting

• Conditions: Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH,

• Registration Number: CTRI/2023/02/050051
• Lead Sponsor: Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal

Brief Summary

AIM &OBJECTIVES

To evaluate the efficacyof *Dashmool ghrit Nasya and Pathyadi Kwath inmanagement          for Ardhavabhedaka (Migraine).*

To compares the effectof only Pathyadi Kwath in the management of Ardhavabhedaka.

STUDY DESIGN:

This study will be designed as a RandomizedControlled clinical study and the participants will be selected from simplepurposive sample technique.

GROUPING:

All the 40 patients of randomly selected will bedivided into 2 groups having 20patients in each group.

GROUP - A: Intervention Group

20 patients of this group will be advised *Dashmool ghrita Nasya and Pathyadi kwath 40 mltwice a day for 21 days.*

GROUP - B: Control Group

20 patients of this group will be keptwith *Pathyadi kwath 40 mltwice a day for 21 days.*

Study duration- 21 Days

Follow up– 1 month

CRITERIA  FOR  DIAGNOSIS :

The diagnosis of the disease will be mainlybased on the signs and symptoms mentioned

in Ayurveda texts and the modern texts.

Headache has at least two of the following fourcharacteristics:-

• Unilateral site.

• Pulsating quality

• Moderate or severe pain intensity

• Aggravation by routine physical activity(eg.walking or Climbing etc)

 During headache at least one of the followingSymptoms should be there:-

• Nausea /vomiting

• Photophobia /Phonophobia

• Headache attack lasting 4-72 hours

• Frequency of attacks 15 days per month.

INVESTIGATION:

• Complete Hemogram

CRITERIA FOR ASSESMENT

The disease is assessed by graded according toHIT- 6Tm. test (Headache impact test) Result will be assessed before and afterthe treatment on the basis of gradations.

TREATMENT REGIMEN

| | | | | |

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

|Procedure

Duration

Drug

DOSE

TIME

|*Marsh nasya*

1-21 days

(7 Days +1 day rest + 7 days + 1 day rest + 5 days Nasya)

*Dashmool Ghrita*

8 bindu in each nostril

morning

|*Shaman Aushadh*

1-21 days

*Pathyadi Kwath*

40 ml Twice a day

Before meal

HYPOTHESES

 NULL HYPOTHESIS -

H0  : Group A (*Dashmool ghrita Nasya*and *Pathyadi Kwath*)and group B *Pathyadi Kwath*are equally effective in themanagement of *Ardhavavbhedaka*(Migraine).

ALTERNATE HYPOTHESIS -

Ha1- Group A (*Dashmool ghrita Nasya*and *Pathyadi Kwath*)is more effective than group B

*Pathyadi Kwath*in the management of *Ardhavavbhedaka*(Migraine).

Ha2- Group B *Pathyadi Kwath*ismore effective than group A (*Dashmool ghrita Nasya*and *Pathyadi Kwath*)in the management of *Ardhavavbhedaka*(Migraine).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-22
• Study Start: 2023-02-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Patient’s between 20 to 60 year of age.
• 2.Patients with signs and symptoms of Ardhavabhedaka according to the Ayurveda Classics and modern text.
• 3.Disease chronicity in between 5 years.
• 4.Patient who fulfill under the Diagnostic criteria.
• 5.Patients those fit for Nasya Karma.
• 6.Patients who have given written consent to participate in the study.
• 7.Standard operative procedure of covid-19 pandemic will be adopted in all patients.

Exclusion Criteria

• 1.Patient’s age below 20 years and above 60years.
• 2.Patients having referred pain in one half of head due to pathology of eye, ear, nose, throat, teeth will be excluded.
• 3.Patients having any other systemic pathology like renal failure, TB, heart disease etc will be excluded.
• 4.Patients having complicated migraine and other neurological disorders.
• 5.Head Injury 6.Childhood headache 7.Headache due to Benign/malignant, growth 8.Lactating and Pregnant women’s.
• 9.Patients who are not willing to written consent to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency,intensity,type of Headache	21 days

Secondary Outcome Measures

Name	Time	Method
Headache has at least two of the following four characteristics:-	• Unilateral site.

Trial Locations

Locations (1)

Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal; 🇮🇳 Bhopal, MADHYA PRADESH, India

Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal

🇮🇳Bhopal, MADHYA PRADESH, India

Dr CHHAYA BAGHEL

Principal investigator

9174010213

chhbghl@gmail.com