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CTRI Number  CTRI/2025/01/079013 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathy for Migraine 
Scientific Title of Study   Understanding and Managing Migraine Cases With Background of Hahnemannian Concept of One -Sided Diseases  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rushiraj Sanjaysinh Solanki 
Designation  M.D. Scholar part - 2 
Affiliation  C.D. Pachchigar College Of Homoeopathic Medicine and Hospital 
Address  C.D. Pachchigar College Of Homoeopathic Medicine and Hospital, Near Navjivan Circle, Udhana Magdalla Road, Surat 395001

Surat
GUJARAT
395001
India 
Phone  9727777567  
Fax    
Email  solankirushiraj27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vismay Rajendra Prajapati 
Designation  M.D. (HOM.) 
Affiliation  C.D. Pachchigar College Of Homoeopathic Medicine and Hospital 
Address  C.D. Pachchigar College Of Homoeopathic Medicine and Hospital, Near Navjivan Circle, Udhana Magdalla Road, Surat 395001

Surat
GUJARAT
395001
India 
Phone  8347375491  
Fax    
Email  vismaypraja@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vismay Rajendra Prajapati 
Designation  M.D. (HOM.) 
Affiliation  C.D. Pachchigar College Of Homoeopathic Medicine and Hospital 
Address  C.D. Pachchigar College Of Homoeopathic Medicine and Hospital, Near Navjivan Circle, Udhana Magdalla Road, Surat 395001


GUJARAT
395001
India 
Phone  8347375491  
Fax    
Email  vismaypraja@gmail.com  
 
Source of Monetary or Material Support  
C. D. PACHCHIGAR COLLEGE OF HOMOEOPATHIC MEDICINE AND HOSPITAL 
 
Primary Sponsor  
Name  C.d Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  C. D. Pachchigar College Of Homeopathic Medicine and Hospital, Near Navjivan Circle, Udhana Magdalla Road, Surat - 395001 
Type of Sponsor  Private 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 
Rushiraj Sanjaysinh Solanki  C.D. Pachchigar College Of Homeopathic Medicine And Hospital  Department Of Organon Of Medicine Second Floor Of C.D. Pachchigar College Of Homeopathic Medicine And Hospital, Near Navjivan Circle, Udhana Magdalla Road, Surat-395001
Surat
GUJARAT 
9727777567

solankirushiraj27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Of C.D. Pachchigar College Of Homoeopathic Medicine And Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G439||Migraine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicine  Dose And Repetition Of Homoeopathic Medicine as per requirement of case Route Of Administration Of Homoeopathic Medicine Orally. Duration 3 Months 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patient of all ages and both sexes are selected.
All socio-economical classes will be considered
 
 
ExclusionCriteria 
Details  Emergency cases. (e.g., like – cerebral vascular stroke, Hypertensive headache, head injury etc).
Subjects with active treatment for any other chronic disease.
Cases with advanced pathological condition.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Remove The Symptoms Of Patient.  Removal Of Symptoms Of Migraine Within Time Period Of 7 To 30 Days. 
 
Secondary Outcome  
Outcome  TimePoints 
To Relief The Patient From Migraine Triggering Factor And Also Relieving From Recurrent Episode Of Migraine With Healthy Life Style  As Per Condition Of Patient  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   31/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/01/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

6

BRIEF  RESUME  OF  INTENDED  WORK:

 

6.1

NEED  FOR  STUDY:

             Migraine is a burning problem in modern civilization as a result of some disorder of nervous system mostly arising from such diverse causes that can strain mental tension, anxiety, overwork itself as major health problem of country and a threat to the national economy in term of loss of working hours and disease control proved inadequate in the conventional way because of analgesic resistance. Here, in such condition, I would like to help the humanity with Homoeopathic science. Once Master Hahnemann, the founder of Homoeopathy, has utilized the word “Divine Science” for Homoeopathy. Here I would try to serve humanity with our “Divine Science” and would like to show the effectiveness of our science in the world.

 

            The concept of migraine, its causation and phenomena depend on the state, social and economical development of the society at the particular time. In the early part of civilization, the social and economical development varies from country to country and from people to people. Even in the same country and people it varies from time to time so it does today. In modern civilization the concept of disease it causes and phenomena are different in different system of treatment, thus Ayurveda, Hekimi, Unani, Allopathy, and Homoeopathy are guided by individualistic concept about the cause, nature and phenomena.

 

 

6.2

REVIEW  OF  LITERATURE:

 

1.Defination

              Migraine is a complex neurological disorder characterized by periodic headaches, typically unilateral, often associated with visual disturbance and vomiting. (1)

 

2.Classification

 

·       Classical migraine – Visual or sensory symptoms precede or          accompany the headache.

·       Common migraine – No Visual or sensory features

                                  Headache, nausea, vomiting and photophobia occur

·       Basilar migraine – Occipital headache, preceded by vertigo, diplopia, dysarthria (Slurred speech), hyperacusis (impaired hearing), visual and sensory symptoms (Brain-stem symptoms), muscle weakness is not part of basilar migraine.

 

 

·       Hemiplegic migraine – Prolonged headache lasting hours or days

                                     Headache is followed by contralateral hemiparesis or hemiplegia; patient may have several attacks affecting  one side of the body, whereas the next attacks may affect the opposite side.

·       Retinal migraine – Loss of vision limited to one eye.

·       Typical aura without headache – Presence of migraine aura without headache (visual aura most common) (1)

 

3.Pathogenesis

          Exact mechanism is unknown; it is the consensus that an attack of migraine consists of a neuromuscular disorder of the intracranial as well as extra cranial vessels. Sequential studies of cerebral blood flow show an initial reduction, which may be localized or generalized followed by increases in blood flow later. The basic cause of these circulatory disturbances is unknown. it is found that blood levels of serotonin, histamine and norepinephrine increases during the attacks. There is also an increase in platelet aggregability. This may account for strokes, which complicates migraine. The headache has been attributed to extreme pulsation of extracranial as well as. intracranial arteries.

          There is now good evidence that in classical migraine there is extreme cerebral oligemia at the onset of the attack. This is often occipital in site but may spread to the parietal and temporal lobes. Oligemia may be secondary to some primary cortical dysfunction, since attack can be set off by neural stimuli like bright light or strong odors. Others believe that vasospasm is responsible for the initial dysfunction.

          During headache phase there is dilatation and edema of the extra cranial arteries and probably some alteration in pain sensitivity in their walls. These vascular changes may be due to fluctuation in blood 5 hydroxy tryptamine levels.

          There is a genetic predisposition. Approximately three” quarters of patients who suffer from migraine have close relatives similarly affected.

          Migrainious attacks may be precipitated by a variety of factors such as menstruation, flashing lights, stress and anxiety. Cheese, chocolate and red wine are all common precipitants and are all rich in tyramine, experimental ingestion of which will often provoke an attack. Reserpine, which liberates 5 hydroxy tryptamines in brain also, can cause migraine. (2)

 

 

 

 

 

4.Clinical Features

 

       The attacks are episodic and start at puberty and continue till late middle life with variable degree of spontaneous remissions. Frequency, duration and severity of attacks may vary in the same individual.

     

       The sign & symptoms of migraine vary among patients.

       The four ‘sign & symptoms’ below are common among patients but are not necessarily experienced by all migraine sufferers:

 

·       The Prodrome (An early symptom indicating the onset of disease or illness, which occurs hours or days before the headache)

·       The Aura which immediately precedes the headache

·       The Headache Phase

·       The Postdrome (Migraine Hangover)

 

·       First Phase or Prodrome:

 

          Prodromal symptoms occur in 40-60% of migraineurs.

          This Phase consists of:

·       Altered Mood

·       Depression or Euphoria (A feeling or state of intense excitement & Happiness)

·       Fatigue

·       Yawning

·       Excessive Sleepiness

·       Craving for certain food (E.g., Chocolate)

 

These symptoms usually precede the headache phase of migraine attack by several hours or days and experience teach the family observant or patient that the migraine attack is near.

 

·       Second Phase or Aura:

 

          The Migraine aura is comprised of ‘Focal Neurological Phenomena’ that precedes or accompany the attack.

         They appear gradually over 5 to 20 minutes & usually subside just before the headache begins.

         Symptoms of migraine aura are usually ‘Sensory’ in nature. (perceived by senses)

         At first this aura may take the form of some ‘Visual Disturbances’ e.g., Photophobia, Cloudy vision, Lachrymation, ocular pain etc.

         The Somatosensory aura of migraine consist of Digitolingual Paresthesia (Always Unilateral) A feeling of pins & needle experience in hand and arm.

       

·       Third Phase or The Headache:

 

         The typical migraine headache is unilateral, throbbing and moderate to severe and can be aggravated by physical activity.

         The pain may be bilateral at the onset or start on one side and become

generalized, usually alternates sides from one attack to the next.

         The onset is gradual. The pain peaks and then subsides, and usually lasts between 4 to 72 hours in adults and 1 to 48 hours in children.

         The frequency of attack is extremely variable, from a few in a lifetime to several times a week, the average migraine experiences from one to three headaches a month.

         The pain of migraine is invariably accompanied by other features:

         Anorexia is common and Nausea occurs in almost 90 % of the patients;

While vomiting occurs in 1/3rd of patient.

         Many patients experience sensory hyperexcitability manifested by photophobia (abnormal sensitivity to light, especially of the eyes), phonophobia (a persistent, abnormal and unwarranted fear of sound),

osmophobia (fear, dislike or aversion to smell or odors) and seek a dark and quiet room.

         Blurred vision, nasal stiffness, diarrhea, polyuria, pallor or sweating may be noted during the headache phase.

         A feeling of faintness may occur, the extremities tend to be cold and moist.

 

·       Fourth Phase or The Postdrome Phase:

 

    The patient may feel tired, ‘washed out’, irritable, listless and may have                                                 impaired concentration and mood changes.

    Some people feel unusually refreshed or euphoric after an attack whereas others note depression and malaise. (3) (4)

 

5.Diagnostic Criteria

 

·       Common Migraine

·       Repeated attacks (at least five attacks) of headache lasting 4-72 hours that have the following features:

·       Normal physical examination.

·       No other reasonable cause for the headache

 

 

·       Headache has at least two of the following:  

    Unilateral pain

    Throbbing or pulsatile pain

    Aggravation of pain by movement

    Moderate or severe intensity of pain

·       At least one of the following during headache:

    Nausea or vomiting

    Photophobia and phonophobia

 

·       Classical Migraine

-   Repeated attacks (at least two attacks) of headache lasting 4-72 hours that have the following features:

-    Normal physical examination.

-    No other reasonable cause for the headache.

-  Aura consisting of at least one of the following, but no motor weakness;

          Fully reversible visual symptoms including positive features (e.g. flickering lights, spots or lines) and/or negative features (e.g. loss of vision)

          Fully reversible sensory symptoms including positive features (e.g. pins and needles) and/or negative features (e.g. numbness) 

          Fully reversible dysphagic speech disturbance

-    At least two of the following:

          Homonymous visual symptoms and/or unilateral sensory symptoms.

          At least one aura symptoms developing gradually over > 5 minutes and/or different aura symptoms occurring in succession over > 5 minutes.

          Each symptom lasting >5 and <60 minutes

Headache begins during aura or follows aura within 60 minutes. (1)

 

6.Differntial Diagnosis (4)

·       Cluster Headache

·       Tension Type Headache

·       Medicine Overuse Headache

·       Viral Meningitis

·       Cerebral Aneurysms

·       Chronic Paroxysmal Hemicrania

·       Intracranial Haemorrhage

·       Encephalitis

 

7.Complication

 

·       Status migrainosus is a debilitating migraine attack that lasts more than 72 hours.

·       Migrainious infarction is one or more aura symptoms associated with brain ischemia.

·       Persistent aura without infarction is an aura that persists for more than one week without evidence of infarction.

·       Migraine aura – triggered seizure occurs during an attack of migraine with aura, and a seizure is triggered. (4)

 

8.Treatment:

 

·       Avoidance of identified triggers or exacerbating factors (such as the combined contraceptive pill) may prevent attacks.

·       Treatment of an acute attack consists of simple analgesia with aspirin, paracetamol or non-steroidal anti-inflammatory agents.

·       Nausea may require an antiemetic such as metoclopramide or domperidone.

·       Severe attacks can be aborted by one of the ‘triptans’ (e.g. sumatriptan), which are potent 5-hydroxytryptamine (5-HT, serotonin) agonists. These can be administered via the oral, subcutaneous or nasal route.

·       Caution is needed with ergotamine preparations because they may lead to dependence.

·       Overuse of any analgesia, including triptans, may contribute to medication overuse headache.

·       If attacks are frequent (more than two per month), prophylaxis should be considered. Many drugs can be chosen but the most frequently    used are vasoactive drugs (β-blockers, candesartan, lisinopril), antidepressants (amitriptyline, dosulepin) and antiepileptic drugs   (topiramate). Monoclonal antibodies to calcitonin gene-related peptide   receptor are available for refractory migraine.

·       Women with aura should avoid oestrogen treatment for either oral contraception or hormone replacement, although the increased risk of ischemic stroke is minimal. (5)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hahnemannian concept of one-sided disease

 

          Chronic diseases which are having too few symptoms are called one sided disease. The availability of symptoms are less in number in such diseases, as a result construction of totality becomes very difficult. Hence, they are difficult to cure (§ 172-173). (6)

 

 - Types of One-Sided Diseases (§ 174) (6)

Depending upon the principle symptom exhibited by the patient, one-sided diseases are classified into 2 types:

·       One-sided disease with internal complaint

·       One-sided diseases with external complaint

 

o   One-sided disease with internal complaint:

These group of diseases exhibit more of the internal symptoms that are mostly affecting the internal parts of the body. They are of again two types:

 

o   Diseases with physical symptoms:

Example: Chronic Headache, diarrhea of long standing, an old cardialgia etc.

o   Diseases with mental symptoms Example: mania, insanity etc.

 

 - Treatment of One-Sided Diseases:

 

           Sometimes it seems that treating one-sided diseases is difficult as the symptoms are not sufficiently present. The portrait of the disease is not sketched properly (§ 175).

           But careful case taking & examination will reveal one or two severe and important symptoms that are present in the case (§ 176).

           Based on these available symptoms, the physician has to select the seemingly indicated remedy which he thinks best suitable (§ 177).

           Such selection is, if based on the very striking, decided, uncommon and peculiar, distinctive symptoms of the patient, the selected remedy sometimes cures the given case (§ 178).

           But frequently owing to the scarcity of symptoms, the chosen remedy may not exactly cover the totality of the given case. When such imperfect homeopathic remedy is administered, patient complains of appearance of new symptoms which he never experienced before. These symptoms are nothing but the "accessory symptoms of the medicine". This should not be considered as a bad prognosis. The whole collection of the existing symptoms has to be considered as the disease picture itself (§ 180-181).

           By considering the accessory symptoms of the medicine as the disease symptoms, the physician gets more number of symptoms of the disease. Thus, the totality of the symptoms of the disease is accurately sketched with the help of accessory symptoms of the medicine. Hahnemann in § 182 says, “the imperfect selection of the medicament, which was in this case almost inevitable owing limited number of symptoms present, serves to complete the display of the symptoms of the disease.”

           Now based on the symptoms of the disease and the newly developed accessory symptoms of medicine, we can prescribe a new yet well-chosen homeopathic remedy.

           Existing symptoms of Disease + Accessory symptoms of Medicine = Present totality of symptoms

           In the footnote to aphorism no. 181, Hahnemann warns that before considering the accessory symptoms of medicine as the totality, the physician has to clarify that the accessory symptoms are not produced due to any error in diet and regimen or due to some menstrual irregularities, conception and child birth etc. It has to be confirmed that the new symptoms are due to administered medicine only.

          When the previously administered remedy completes its action, the present symptomatology and the state of the disease remaining (status morbi) has to be enquired thoroughly. Based on this current totality, a new homeopathic remedy has to be selected and administered again (§ 182-183).

           Sometimes it happens that even when the patient is ill and suffering the symptomatology may not be sufficiently clear and distinctive. In such condition administration of "Opium" will help to clear the paucity of symptoms. Opium, in its secondary action makes the   patient’s pain and suffering clearer and more perceivable to the physician (footnote to § 183).

           In this way, based on the existing and remaining totality several remedies can be administered one after another in succession. Each prescription has to be done only after the pervious one has completed its action. The same method can be practiced until the recovery is complete and the patient gets cured. (7)

 

 

OBJECTIVE  OF  THE  STUDY:

 

·       To study the mode of clinical presentation of migraine.

·       To study the idea of one-sided disease focusing in point of view of migraine in details.

·       To assess the effectiveness of Hahnemannian direction in cases of migraine.

 

 

 

7

material  and  methods:

 

7.1

SOURCES  OF  DATA:

Project site – C.D. Pachchigar college of homoeopathic medicine and hospital. – OPD.

 

7.2

MATERIALS:

1.College OPD standard case taking format.

2.Synthesis Repertory by Frederik schroyens, MD. 

3.Consent form of patient.

4.Various books of allied science, materia medica and organon of medicine.

7.3

METHOD  OF  COLLECTION  OF  DATA:

1.Study design – Experimental study

2.Study type – Prospective study

3.Study population – Cases having complaint of Migraine who treated with homoeopathic medicine at c.d. Pachchigar college of homoeopathic medicine and hospital.

4.Sample size – Minimum 30 cases

5.Sampling techniques-simple randomization

6.Selection criteria.

 Inclusion criteria

- Patient of all ages and both sexes are selected.

- All socio-economical classes will be considered

 Exclusion criteria

- Emergency cases. (e.g., like – cerebral vascular stroke, Hypertensive headache, head injury etc).

- Subjects with active treatment for any other chronic disease.

- Cases with advanced pathological condition.

 

 

 

 

·       Case taking will be done according to guidelines mentioned by Dr.

Hahnemann in Aphorisms 83-104 & College O.P.D standard case taking format.

·       After proper analysis and evaluation of symptoms, totality of symptoms will be formed.

·       Totality formation will be done as per the instructions given by Dr.

Hahnemann in organon of medicine.

·       Investigations for diagnosis of the disease will be done as per the

requirement of the case.

·       The remedy will be selected on the basis of totality of symptoms and

either from reportorial or non-reportorial approach.

·       The remedies will be used in various potency as per the requirement of the cases.

·       Remedies will be administered as per guidelines given by Dr.

Hahnemann in organon of medicine.

·       The remedies will be repeated as per the requirement of the case.

·       Homoeopathic remedies will be dispensed from C.D. PACHCHIGAR College & hospital homoeopathic pharmacy.

·       Response will be analysed as per following criteria:

 

 

          The analysis of the result will be done according to response obtained after treatment.

1)    Significant improvement – Sense of well-being with no presenting complaints and no relapse of symptoms at least for six months.

2)    Mild Improvement – Patient who are relieve from presenting complaint in intensity and/or duration of symptoms.

3)    Status quo – There is neither increase nor decrease in the intensity or frequency and duration of presenting complaints.

4)    Deterioration – There is increase in intensity of symptoms despite of taking proper medicine at regular interval.

5)    Follow up cases will be done at every 7,15,21,30 days as per requirement of case  

 

 

 

 

 

 

              

 

7.4

DOES  THE  STUDY REQUIRING  ANY INVESTIGATION  TO  BE CONDUCTED  ON PATIENTS  OR  OTHER HUMANS  OR  ANIMAL?

As per requirement of the case

 

 

7.5

 

 

 

HAS  ETHICAL CLEARENCE  BEEN OBTAINED  FROM  YOUR INSTITUTE?

 

 

YES

 

 

 

 

 

 

 

 

 

 

 

 

 8

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BIBLIOGRAPHY:

 

1.

AGGRAWAL KGM&P. MEDICINE Prep Manual for Undergraduates. 5th ed.: ELSEVIER; 2002.

2.

DR. RAJITHA K NAIR MASotEoH. https://www.homeobook.com/migraine-a-study-on-the-effectiveness-of-homeopathy/. [Online]. Available from: https://www.homeobook.com/migraine-a-study-on-the-effectiveness-of-homeopathy/.

3.

Golwalla AFG&SA. Golwalla’s medicine for students , A Reference Book for The Family Physician. 25th ed.: Jaypee Brothers Ltd Pvt; 2017.

4.

Marco A PR, Headache ODJM. https://www.ncbi.nlm.nih.gov/books/NBK560787/. [Online]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560787/.

5.

Davidson S. Davidson’s Principles and Practice of Medicine. 24th ed.: ELSEVIER.

6.

Hahnemann S. Organon of Medicine. 6th ed.: B Jain.

7.

Babu DGN. Comprehensive Study of Organon An Attempt To Understand The Organon Of Medicine as a Scientific Treatise: B. Jain.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
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