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Clinical Trials/CTRI/2026/01/102208
CTRI/2026/01/102208Not yet recruitingPhase 2

An Open Label clinical trial to evaluate the efficacy of selected Panchkarma Procedures in the management of Anantvata with special reference to Trigeminal Neuralgia

National Institute of Ayurveda1 site in 1 country30 target enrollmentStarted: July 1, 2026Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Enrollment
30
Locations
1

Study Overview

Brief Summary

Trigeminal Neuralgia is the most debilitating form of neuralgia affecting the sensory branches of 5th cranial nerve (Trigeminal nerve). Trigeminal Neuralgia (TN) is a unilateral disorder characterized by excruciating paroxysmal severe, brief, stabbing, lancinating, recurring pain in the distribution of one or more branches of Trigeminal nerve affecting ear, lips, gums, cheek, or chin and very rarely in the distribution of the ophthalmic division of the trigeminal nerve. The ‘typical’ or ‘classic’ form of the disorder (Type 1 or TN 1) causes extreme sporadic sudden burning or shock like facial pain that lasts anywhere from a few seconds to as long as 2 minutes per episode. The ‘atypical’ form of the disorder (Type 2 or TN 2) is characterized by constant aching, burning, stabbing pain of somewhat lower intensity than type 1. Chewing, speaking, washing the face, tooth brushing, cold winds or touching a specific ‘trigger spot’ e.g. upper lip or gum may all precipitate an attack of pain. TN more commonly affects females and patients over 50yrs of age. The Pain rarely occurs bilaterally and never simultaneously on each side; occasionally more than one division is involved. In Ayurveda Acharya Sushruta has described disease named Anantvata under 11 Shirorogas. In this disease all the three Doshas are vitiated. Hence the disease is said to be Tridoshaj Vyadhi. While explaining the symptoms of the disease Acharya has said that the Doshas affect the Manya which is Siramarma and causes severe pain in the Ghata that is the Prushtha Bhaga of the Griva (back side of the neck), Akshi (eyes), Bhru (eyebrows), Shankha Pradesha (temples). There is also Spandan in the Ganda Parshva Pradesha (spasm in the cheek), Netrarogam (eye diseases) and Hanugraham (spasm of temporomandibular joint). According to signs and symptoms, Anantavata can nearly correlate with Trigeminal Neuralgia. Trigeminal neuralgia affects 4 to 13 out of every 100,000 people per year. It is more common in women than in men, with a female-to-male prevalence ratio ranging from 1.5 to 1.7 to 1. Most cases occur after the age of 50, but the condition can also appear in people in their 20s and 30s, though it is rarely diagnosed in childhood. Research on Trigeminal Neuralgia is important because it is a severely disabling pain condition that greatly affects quality of life. Currently, there is no definitive cure, making it necessary to further investigate its underlying mechanisms in order to develop more effective and targeted treatment options. Carbamazepine is the first-line treatment for trigeminal neuralgia.  However, in this case, despite taking these medications for a long time, the patient did not experience significant improvement. Modern science is pharmacological and surgical but not effective as recurrence is very common. In ayurveda anantvata is managed according to dosha and their adhisthana. Anantavata is urdwajatrugata vikara for which nasya is considered best modality. Shaman chikitsa after Shodhan is required for better outcomes.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
40.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age group between 40-60yrs Paroxysmal attacks of pain lasting from a fraction of a second to 2 min affecting one or more divisions of the trigeminal nerve.
  • Pain has at least one of the following characteristics Intense, sharp, superficial or stabbing Precipitated from trigger areas or by trigger factors.
  • Attacks are stereotyped in the individual patient.
  • Patients having clinical signs and symptoms of Anantvata like Manyapaschad ghatasu vednam (pain in sternomastoid region and at the back of neck) Spandnam gandasyaparshwa(throbbing pain in sides of cheeks) Netraroga(eye diseases) Hanugreham (lock jaw) Tivra kurvati akshibrhushankhevavtishthe (Pain in eyes and along the eyebrows).

Exclusion Criteria

  • Having undergone Trigeminal Neuralgia-related surgical treatment.
  • Having a clear history of neurological diseases such as brain trauma, Cerebral Hemorrhage, or Brain Tumors.
  • Patients with a history or risk of seizures or a history of Epilepsy, Head injury or related Neurological disorders.
  • Patients with a history of poorly controlled and uncontrolled Hypertension (above150/100 mm of Hg) Pregnant and Lactating women.

Investigators

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Priya Sharma

National Institute of Ayurveda

Study Sites (1)

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