FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092727 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On: 24/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   A study to see if LM potency of homoeopathic medicine can help manage migraine 
Scientific Title of Study   Efficacy of LM potency in cases of migraine 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rutvi Kamleshbhai Mohite 
Designation  M D Scholar Part 2 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Department of Homoeopathic Pharmacy Division of MD 2nd Floor C D Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhna Magdalla Road Surat

Surat
GUJARAT
395001
India 
Phone  7405550880  
Fax    
Email  rutvimohite8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Santosh Mahale 
Designation  Professor of Homoeopathic Pharmacy Department 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Department of Homoeopathic Pharmacy Division of MD 2nd Floor C D Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhna Magdalla Road Surat

Surat
GUJARAT
395001
India 
Phone  9825290925  
Fax    
Email  rajeshmahale4u@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Santosh Mahale 
Designation  Professor of Homoeopathic Pharmacy Department 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Department of Homoeopathic Pharmacy Division of MD 2nd Floor C D Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhna Magdalla Road Surat

Surat
GUJARAT
395001
India 
Phone  9825290925  
Fax    
Email  rajeshmahale4u@gmail.com  
 
Source of Monetary or Material Support  
C D Pachchigar College of Homoeopatic Medicine And Hospital Near Navjivan Circle Udhna Magdalla Road Surat India 395001 
 
Primary Sponsor  
Name  C D Pachchigar College of Homoeopatic Medicine And Hospital 
Address  C D Pachchigar College of Homoeopatic Medicine And Hospital Near Navjivan Circle Udhna Magdalla Road Surat  
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 
Dr Rutvi Kamleshbhai Mohite  C D Pachchigar College Of Hooeopathic Medicine And Hospital  C D Pachchigar College of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhna Magdalla Road Surat 395001
Surat
GUJARAT 
7405550880

rutvimohite8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committtee 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: G43||Migraine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HOMOEOPATHIC MEDICINES  Homoeopathic medicine will be prescribed on the basis of totality of symptoms and individual susceptbility. The medicine will be administered orally and potencies are selected according to case and the intervention will be done on 7 to 30 days (depending on case) 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patient of 12 to 50 years of age groups and all sexes wil be considered irrespective of socioeconomic conditions  
 
ExclusionCriteria 
Details  Patient with any malignant condition
Complications of migraine : migrainous infarction, migraine aura trigger seizure
Patient having serious illness in between 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study efficacy of LM potency in cases of migraine headache   9 months 
 
Secondary Outcome  
Outcome  TimePoints 
To study efficacy of individualized homoeopathic medicine in cases of migraine  9 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   14/08/2025 
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="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  

NEED FOR STUDY:

Globally, headache disorders affect approximately 40 percentage of the population, or 3.1 billion people in 2021, and are more common in females compared to males. Not only is a headache painful, but it is also disabling. According to Global Health Estimates 2019, headache disorders were found to be third highest cause of disability-adjusted life years (DALYs) worldwide, after stroke and dementia(1) and according to Lancet neurology migraine was the second cause of disability after low back pain and ranked among the top ten causes of YLDs(years of life lived with disability) (age-standardised) in all 195 countries, both in 1990 and in 2016. (2)

At present, the commonly used clinical drugs for migraine treatment mainly involve non-steroidal anti-inflammatory drugs (NSAIDs), opioids, and triptans. In addition, NSAIDs may induce gastrointestinal and cardiovascular diseases. Moreover, the frequent use of opioids may lead to medication-overuse headache (MOH), and also have the risk of addiction. Invalid treatment and drug abuse in the acute phase of migraine can worsen the condition from acute to chronic, causing greater burden to patients and society. (3)It’s important to explain to the cases at the onset that they’ve been born with a sensitive neurovascular system that overreacts to internal changes or external stimulants, and there’s a veritably good chance that the condition can be brought under control by advice and proper homeopathic drug with proper selection of potency.

In homoeopathy selection of potency is as much integral part of the process of making homoeopathic prescription as the selection of the remedy. In homoeopathy three scales are used decimal scale, centesimal scale and 50 millesimal scale.The discovery of 50 millesimal potency is said to be perfect method of potentization.Although, LM potency has got great advantages like, possibility of frequent repetition, least aggravation and least quantity of material, it doesn’t use widely compared to other potency.Considering all this points I want to study and prove efficacy of LM  potency of homoeopathic medicine in cases of migraine.

REVIEW OF LITERATURE:

The word migraine is French in origin and comes from the Greek hemicrania, as does the Old English term megrim. Literally, hemicrania means "half (the) head." (4)Migraine is a common disabling primary headache disorder. Many epidemiological studies have documented its high prevalence and socio-economic and personal impacts. (5) Migraine is usually an episodic headache associated with certain features such as sensitivity to light, sound, or movement; nausea and vomiting often accompany the headache. A useful description of migraine is a recurring syndrome of headache associated with other symptoms of neurologic dysfunction in varying admixtures. (6)

A migraine attack has three phases:    Premonitory (prodrome), Headache phase and Postdrome

Each has distinct and sometimes disabling symptoms, which may overlap. About 20-25 percentage of migraine patients have a fourth, aura, phase. Migraine can often be recognized by its activators, referred to as triggers.(6)Migraineurs are particularly sensitive to environmental and sensory stimuli; migraine-prone patients do not habituate easily to sensory stimuli. This sensitivity is amplified in women during the menstrual cycle. Headache can be initiated or amplified by various triggers, including glare, bright lights, sounds, or other types of afferent stimulation; hunger; let-down from stress; physical exertion; stormy weather or barometric pressure changes; hormonal fluctuations during menses; lack of or excess sleep; and alcohol or other chemical stimulation, such as with nitrates. Knowledge of a patient’s susceptibility to specific triggers can be useful in management strategies involving lifestyle adjustments, although it is becoming recognized that some apparent triggers may in fact be part of the initial phase of the attack; i.e., the premonitory phase or prodrome.(6)

Classification according to ICHD -3: (5)


1.Migraine


1.1 Migraine without aura

1.2 Migraine with aura

1.2.1 Migraine with typical aura

1.2.1.1 Typical aura with headache

1.2.1.2 Typical aura without headache

1.2.2 Migraine with brainstem aura

1.2.3 Hemiplegic migraine

1.2.3.1 Familial hemiplegic migraine (FHM)

1.2.3.1.1 Familial hemiplegic migraine type 1 (FHM1)

1.2.3.1.2 Familial hemiplegic migraine type 2 (FHM2)

1.2.3.1.3 Familial hemiplegic migraine type 3 (FHM3)

1.2.3.1.4 Familial hemiplegic migraine, other loci

1.2.3.2 Sporadic hemiplegic migraine (SHM)

1.2.4 Retinal migraine

1.3 Chronic migraine

1.4 Complications of migraine

1.4.1 Status migrainosus

1.4.2 Persistent aura without infarction

1.4.3 Migrainous infarction

1.4.4 Migraine aura-triggered seizure

1.5 Probable migraine

1.5.1 Probable migraine without aura

1.5.2 Probable migraine with aura

1.6 Episodic syndromes that may be associated with migraine

1.6.1 Recurrent gastrointestinal disturbance

1.6.1.1 Cyclical vomiting syndrome

1.6.1.2 Abdominal migraine

1.6.2 Benign paroxysmal vertigo

        1.6.3 Benign paroxysmal torticollis

Diagnostic criteria for migraine: (6)

Repeated attacks of headache lasting 4 – 72 hr in patients with a normal physical examination, no other reasonable cause for the headache, and:

·       At least 2 of the following features:

 Unilateral pain

  Throbbing pain

  Aggravation by movement

  Moderate or severe intensity

·       Plus at least 1 of the following features:

  Nausea/ vomiting

 Photophobia and phonophobia

NONPHARMACOLOGIC MANAGEMENT (6) Migraine can often be managed to some degree by a variety of nonpharmacologic approaches. When patients can identify reliable triggers, their avoidance can be useful. A regulated lifestyle is helpful, including a healthy diet, regular exercise, regular sleep patterns, avoidance of excess caffeine and alcohol, and avoidance of acute changes in stress levels, being particularly wary of the let down effect.

Homoeopathy aspectMigraine is type of disease which comes under the bracket of one sided disease (aphorism-172- 184) given by master Hahnemann in organon of medicine.According to aphorism – 275 in Hahnemann’s organon of medicine “The suitableness of a medicine for any given case of disease does not depend on its accurate homoeopathic selection alone, but likewise on the proper size, or rather smallness, of the dose. (7)

Different scales of potentisation: (8)

In homoeopathy three scales are used decimal scale, centesimal scale and 50 millesimal scale.According to Stuart close “Homoeopathic dynamisation is a mathematico mechanical process for reduction according to scale, of crude, inert or poisonous medicinal substances to a state of physical solubility, physiological assimilability, therapeutic activity and harmlessness, for use as homoeopathic healing remedies.

In the preface of the Organon, 5th edition. Hahnemann stated that Homoeopathy was "so near to perfection." But about the 6th edition he wrote to his publisher that in comparison with the previous ones it was "the most nearly perfect of all." So the 5th edition was near to perfection but not quite perfect, whereas the 6th edition is the most complete of all upto the time of Hahnemann. (9)Medicinal aggravations which are the common features of the centesimal scale no longer exist in the new method. "Such increase of the original symptoms of chronic disease can appear only at the end of the treatment when the cure is almost or quite finished."(Hahnemann, S: ibid., Apho. 161.) So, the question of"... furious, even dangerous, violence" (Hahnemann, S: ibid., footnote 155 to Apho 270.) of centesimal scale does not arise in 50 millesimal scale. (9)In comparison with the medicine of centesimal scale, this new method "produces medicines of highest development of power and mildest action." (Hahnemann, S: ibid, footnote 155 to Apho 270.) (9)But, on the other hand, new dynamization method diminishes this period to "one half, one-quarter and even still less, so that a much more rapid cure might be obtained."(Hahnemann, S: Organon, sixth ed., Apho 246.) (9)L.M. scale is the finer and latest scale of potency, introduced in the 6th edition of Organon of Medicine, prepared in the ratio 1:50,000. (8)

 
Close