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临床试验/CTRI/2025/08/093249
CTRI/2025/08/093249尚未招募2 期

A randomized controlled clinical trial to study the effect of Rasnadyo Guggulu in the management of ardhavabhedaka with special reference to simple migraine.

Dr Prajakta Pundalikrao Akate1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年8月29日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Reduction in signs and symptoms of ardhavabhedaka after taking rasnadyo guggulu

研究概览

简要总结

Ayurveda has given prime importance to Shira where the Prana i.e. life

exists. Acharya Charaka considered Shira as the supreme important and major

part of the body which is known as Uttamang. Ardhavabhedaka is a Shiroroga which is mentioned in multiple

literature of Ayurveda.

Usually there is radiating and throbbing  pain in  head in Ardhavabhedaka.

It is sadhya  type of Shiroroga . Ardha means half side of the head and Bhedaka means perforating type of

pain it is the disease having symptoms of Uttamanga ardhabhaga sambhedana toda, bhrama Rasnadyo Guggulu  is the drug which is  Shiroroghar.   Therefore, it can be used to treat Ardhavabhedaka. It contains rasna, guggulu, devdaru, guduchi, suntha, eranda.

Individually have various guna like vataghna, pittaghna, kaphaghna, shulaghana, tridoshaghna which when taken together will definitely found to be beneficial in treating ardhavabhedaka, so rasnadyo guggulu can be used as best alternative to caffeine ergotamine tablets.

Inclusion criteria a)Patients having Lakshanas of Ardhavabhedaka or simple migraine.

b)Patients between age group of 18-60 years.

c)Patients will be included irrespective of sex, religion and caste.

B]Exclusive criteria:

a) Patients with complicated migraine, hemiplegic migraine.

b) Patients age below 18 years and above 60 years.

c)Patients having a history of head trauma and other types of headaches.

d) Patients having any inflammatory diseases in nose ,PNS ,eyes and ears.

e) Patients suffering from other diseases like HIV,DM,HTN, pregnant

women .

Patient will be selected from signs and symptoms mentioned in classical texts and are selected irrespective of sex, socioeconomic status and community, written consent from patient will be taken to prior to study. Computerised generated sampling technique will be used. Total 70 number of patients will be selected and divided into two groups, named as Group A (trial group) and Group B (control group). Rasnadyo guggulu Group A (trial group) with dose 300 mg equivalent to dose 1 mg caffeine and 100 mg ergotamine tablet Group B (Control group) once a day will be given to patients. Both drugs will be administered in tablet form for 15 days. Observations will be done on day 0 day, 5th day, 10th day and 15th day and follow up on 31st day. Result of study will be drawn on the basis of criteria of assesment and statistical analysis. Discussion will be done on the basis of observations and result obtained during the treatment. Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • a)Patients having lakshanas of ardhavabhedaka or simple migraine b)Patients between age group og 18 to 60 years c)patients will be included irrespective of sex, religion and caste.

排除标准

  • a)Patients with complicated migraine/hemiplegic migraine b)patients age below 18 years and above 60 years c)patients having a history of head trauma and other types of headaches d)patients having any inflammatory diseases in nose, PNS, eyes and tears e)patients suffering from other diseases like HIV, DM, HTN, pregnant women.

结局指标

主要结局

Reduction in signs and symptoms of ardhavabhedaka after taking rasnadyo guggulu

时间窗: 15 days

次要结局

  • where the trial group stands in comparison with control group in reduction with sign and symptoms of ardhavabhedaka(18 months)

研究者

发起方
Dr Prajakta Pundalikrao Akate
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Prajakta Pundalikrao Akate

SMBT Ayurved college and Hospital

研究点 (1)

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