跳至主要内容
临床试验/CTRI/2024/05/067428
CTRI/2024/05/067428尚未招募Phase 3 4

Clinical study to evaluate the efficacy of Pathyadi Kwath along with Rasnadi taila Nasya as described in Ayurveda Samhitas in the management of Ardhavabhedaka w.s.r to Migraine.

Govt Auto Ayurveda College and Hospital Nipaniya Rewa1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月27日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Improvement in subjective parameters like headache, vertigo, nausea, vomiting, photophobia, phonophobia

研究概览

简要总结

TITLE  -

“CLINICAL STUDY TO EVALUATE THE EFFICACY OF PATHYADI KWATH ALONG WITH  RASNADI  TAILA  NASYA AS DESCRIBED IN AYURVEDA SAMHITAS IN THE MANAGEMENT OF ARDHAVABHEDAKA W.S.R. TO MIGRAINE”.

AIMS & OBJECTIVE -

·       To evaluate the efficacy of Pathyadi kwath and Rasnadi  Taila Nasya in the management of Ardhavabhedaka ( Migraine).

To assess the effect of trial drugs in improving the signs, symptoms as per assessment criteria and HIT-6 Test.

INTRODUCTION :-

Our ancient sages have described three vital organs and have given prime importance to head i.e., Shirah, as the existence of body depends upon the vital organ.Shirah is that part of the body where life along with sense faculties resides.

Almost all our ancient Acharayas have mentioned about the Shiro-roga of which Shirah-shoola as the main symptom and also they have taken Shirah-shoola as the synonym of Shiro-roga. Ardhavabhedaka is a Shiroroga mentioned in various texts of Ayurveda. Some Acharyas has been classified as Vataja, Vatakaphaja and Tridoshajaroga.

Ardhavabhedaka etiology and symptoms are most appropriately related to migraine hence it can be co-related with Migraine headache of Modern medicine.

Migraine being a primary headache, affects one in seven globally and  is the second most common  type of neurovascular headaches. It is the third most common disease in the world characterized by recurrent headaches that are moderate to severe and seventh highest specific cause of disability worldwide (GBD 2012).  â€œTypically in Migraine, the headaches affect one half of the head, are pulsating in nature, and last from 4 to 72 hours. Associated symptoms may include nausea, vomiting, and sensitivity to light, sound, or smell.”

NEED OF THE STUDY:-

Ø  In Present Scenario the incidence of migraine is increasing day by day. It affects the personal, social, and economic life of a person.

Ø   Person wants instant relief in migraine.

Ø  In Modern Medical Science, there is only symptomatic treatment of migraine, for example NSAIDS group, Beta blocker, anti-seizure, antidepressant, calcium channel blocker etc. and long-term use of these drugs can lead to stomach ulcers, hepatotoxic, renal problem, decreased heart function, asthma and many more.

Ø   So, to get out of these problems we need Alternative approach of management.

Study Design :-

Study Type                 :          Interventional Purpose                        :          Treatment Masking                      :          Open Labelled, Clinical trial Direction                     :          Prospective End point                     :          Efficacy No. of Groups             :          Single Group Sample size                 :          30 Patients

Probable Mode of Action of Drug :-

Ø  Pathyadi Kwath is tikta kashaya rasa pradhana, having madhur vipaka and ushna veerya with laghu & ruksha guna predominance.

Ø  Practically most of the patients with migraine are seen having hyperacidity, history of consumption of street food, spicy food, night out, stressful lifestyle these are described as pitta prakopaka hetus in Ayurveda, which are responsible for nausea, vomiting, vertigo.

Ø  So considering pitta predominance in Ardhavabhedaka tikta kashaya and madhur vipaka of Pathyadi kwath will be best pittashamaka dravya.

Ø  Katu and tikta rasa of pathyadi kwath have deepana, pachana karma that helps to improve metabolism by the property of Amapachana.

Ø  Ushna veerya of pathyadi kawth act as stroto shodhaka and kleda shoshaka; eliminate morbid doshas accumulated in the body.

Ø  Though the percentage of ushna veerya dravya are 57% it is not that high to cause pitta prakopa rather it balances associated kaphadosh in Ardhavabhedaka.

Ø  In addition, laghu and ruksha guna act as kleda shoshaka, mala of kapha dosh.

Ø  Nasya aushadhi reaches to brain via nasal route and acts on higher centers of  brain  controlling  different  neurological,  endocrinal  and circulatory  functions  and  thus  showing  local  as  well  as systemic   effects.

All we can say pathaydi kwath and nasya can break the samprapti of Ardhavebhedaka.

TREATMENT  REGIMEN :-

PROCEDURE

DURATION

DRUGS

DOSE

TIME

|Pratimarsh nasya

8 weeks

Rasnadi Taila

2 Bindu

In each nostril

Morning- Evening

|Shaman Aushadh

8 weeks

Pathyadi Kwath

40 ml

Twice a day

Before meal

Duration– 8 weeks

Follow up – 6 MONTHS

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
16.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with signs and symptoms of Ardhavabhedaka according to the Ayurveda Classics and Modern text.
  • 2.Patient who fulfill under the Diagnostic criteria.
  • 3.Patients suitable for Nasya Karma.
  • 4.Patients who have given written consent to participate in the study.

排除标准

  • Patients having referred pain in one half of head due to pathology of eye, ear, nose, throat, teeth will be excluded.
  • Patients having any other systemic pathology like renal failure, TB, heart disease etc will be excluded.
  • Head Injury.
  • Headache due to Benign/Malignant growth.
  • Lactating and Pregnant women.
  • Patients who are not willing to written consent to participate in the study.
  • Chakshurindriya / Shrotrendriya Vinasha Patients.

结局指标

主要结局

Improvement in subjective parameters like headache, vertigo, nausea, vomiting, photophobia, phonophobia

时间窗: from 0 days to 8 weeks

次要结局

  • To assess the effect of trial drugs in improving the signs, symptoms as per assessment criteria & HIT-6 test.(After 8 weeks)

研究者

发起方
Govt Auto Ayurveda College and Hospital Nipaniya Rewa
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Pritesh Sahu

Govt. Auto. Ayurveda College and Hospital, Nipaniya Rewa

研究点 (1)

Loading locations...

相似试验