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临床试验/CTRI/2024/11/076518
CTRI/2024/11/076518尚未招募2/3 期

A COMPARATIVE CLINICAL STUDY ON VAMANA KARMA USING MADANAPHALA PIPPALI PROCESSED WITH DIFFERENT BHAVANA DRAVYAS WITH ITS PHYTOCHEMICAL ANALYSIS IN HYPOTHYROIDISM

DR VIDYASHREE ASHOK GHANTI1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
After treatment, expected to bring raised TSH to normal TSH level and relief from symptoms

研究概览

简要总结

Samshodhana is the purificatory measure of eliminating morbid doshas from the body and cure the disease from its root cause, hence prevents its recurrence. Vamana karma is one among the effective purificatory therapy and the prime modality of treatment mentioned for Kaphaja disorders by which vitiated doshas are expelled out through *mukhamarga.*In classics larger number of formulations are described for the Vamana karma, among them Madanaphala is said to be the best because of its anapayitva guna.  Ideal medicine is the one which is given in alpamatra, induces mahavega, which is bahudoshahara, sukhashodhaka, laghupaka, sukhaswada and vyadhinashaka. Apart from matra and anupana the efficacy of drug also depends on proper collection of the drug during appropriate season and time, processing and storage. With an appropriate samskara even a small quantity of drug may produce better effect. Bhavana is one among such samskara which is told under the processing of Madanaphala.

 Bhavana samskara enhances the potency of the drug by imbibing the qualities of bhavana dravya. Inclassics different bhavana dravyas have been mentioned for processing of Madanaphala.  Acharya Charaka and Vagbhata have mentioned the use of Ghrita, Dadhi, Madhu and Palala as bhavana dravyas, whereas Acharya Sushruta mentioned only three bhavana dravyas namely Dadhi, Madhu and Palala. Here, quality ofthedrug can be assured by proper collection of drug and potency by classical processing method. Quality andpotency of herbal drug is the need of present day in order to confirm its therapeutic value.

    Vamana karma is indicated in many of the Kaphaja vyadhis, one among them is   Galaganda. In Galaganda, vata and kapha together with meda getting localized in the gala pradesha produces swelling. Kaphaja galaganda can be considered similar to Hypothyroidism. It is one of the common endocrine disorder resulting from deficiency of thyroid hormone. The prevalence of Hypothyroidism in the overall population is 10.95% of which 3.47% were previously undetected and 7.48% were self-reported case. Prevalence increases with age and is higher in females than in males. General features are weight gain, dry skin, constipation, intolerance to cold, fatigue, loss of hair. Untreated hypothyroidism can contribute to hypertension, dyslipidemia, infertility, cognitive impairment and neuromuscular dysfunction. Hormonal replacement therapy is the line of treatment in contemporary science which has adverse effects like mood swings, heat sensitivity, edema of hands, feet and ankle. Studies have shown the effectiveness of Vamana karma in the management of Hypothyroidism.

                    There are many studies conducted on Vamana karma with Madanaphala but none of the studies have been done on individual bhavana dravya. As the potency of the drug will get increase by proper bhavana, this study is selected to see the efficacy of individual and combined effect of bhavana dravyas along with its phytochemical analysis. Hypothyroidism has been selected in the present study as it is indicated for Vamana karma.Here Moorchita tila taila for snehapana and abhyanga is selected based on the involvement of dosha. Hence the study with title “A comparative clinical study on Vamana karma using Madanaphala pippali processed with different bhavana dravyas with it’s phytochemical analysis in Hypothyroidism” is planned to develop some evidence in this regard.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1 Subjects diagnosed with Hypothyroidism who are with raised TSH levels.
  • 2 Subjects fit for Vamana karma.
  • 3 Subjects aged between 20-60 years irrespective of sex.

排除标准

  • 1 Subjects with uncontrolled Diabetes Mellitus, Hypertension, Cardiac disease, Congenital anomalies and Carcinoma of the thyroid gland, which may interfere with the treatment.
  • 2 Pregnancy and lactating women.

结局指标

主要结局

After treatment, expected to bring raised TSH to normal TSH level and relief from symptoms

时间窗: Both subjective and objective parameters except thyroid profile will be assessed and compared on | Before treatment On 0th day | After completion of the treatment On 16th day | Follow up On 45th day | Thyroid profile will be assessed before treatment (D-0) and after treatment (D-45).

次要结局

  • To enhance the quality of life by reducing the sufferings in the patient(Both subjective & objective parameters except thyroid profile will be assessed & compared on)

研究者

发起方
DR VIDYASHREE ASHOK GHANTI
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR SHAKUNTALA S P

GOVERNMENT AYURVEDA MEDICAL COLLEGE BENGALURU

研究点 (1)

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