Evaluation of the safety & efficacy of Zandu Nityam Tablet incomparison to Zandu Nityam Churna in the management of Malavrodha w.s.r.t. Functional Constipation : A RCT
概览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- Emami limited , Kolkata
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Zandu Nityam Tablet is non-inferior to Zandu Nityam Churna in improving bowel movement frequency and stool consistency
概览
简要总结
BACKGROUND
Constipation is a heterogeneous, multifactorial disorder. Patients with constipation present with a varying set of symptoms, including infrequent bowel movements, defecatory disorders, and hard stool consistency. The prevalence of constipation is approximately 16%, with female predominance, and increases with age. Although it is not fatal in most cases, chronic constipation can result in decreased work productivity, impaired quality of life, and increased healthcare costs.
Guidelines recommend a stepwise approach for the management of constipation. After initial lifestyle modifications, bulking agents and osmotic laxatives are recommended as first-line pharmacologic treatments. However, more than half of patients are not sufficiently satisfied with their treatment. Patient satisfaction with treatment varies, and alternative conservative management is widely used by patients with constipation.
Malavrodha is a condition caused by vitiation of Vata Dosha especially Apana Vata along with Agnimandya. Malavrodha as a separate disease entity is not mentioned in the Ayurveda classics, but described as either symptom or complication in association with many diseases. Vata Prakopaka Ahara and Vihara are the prime causes of Malavrodha. This can be understood as improper dietary habits and lifestyle and constant mental stress that results in disturbances of Agni and Apanavata. Agnimandya and Apana Vata Dushti are invariably present in the Samprapti of the Vibandha along with derangement in the function of Pachaka Pitta, Avalambaka Kapha and Samana Vata. Early intervention, dietary modifications like fiber rich food, proper toilet training helps to relieve constipation and prevents further complications.
Nityam churna & Nityam Tablet are well-known Ayurvedic product being marketed in India to overcome the symptoms of functional constipation. Both the products contains standardized Ayurvedic ingredients. The major ingredients are Triphala, swarnapatri, eranda taila, saunf, sanchal along with other Ayurvedic ingredients, which are well known to have laxative properties and helps to improve intestinal movement, maintains gut health, eases bowel movements, soothes the intestine, relives intestinal cramps, cleanses colon and relives stomach bloating.
| Study Title: |
Evaluation of the Safety & Efficacy of Zandu Nityam Tablet in comparison to Zandu Nityam churna in the management of Malavrodh w.s.r.t. functional Constipation: A RCT
|Type of study
Drug trial –Poly herbal Ayurvedic medicines
|Study Design
Single Centre, Randomized, Open label, control clinical trial.
|Objective
Primary Objective
To evaluate the efficacy of Zandu Nityam Tablet in comparison to Zandu Nityam Churna in the management of Malavrodha w.s.r.t. Functional Constipation
Secondary Objective
To validate the clinical efficacy of Zandu Nityam Tablet in comparison to Zandu Nityam Churna on the basis of scientific parameters in the patients suffering from Malavrodha w.s.r.t. functional constipation.
To evaluate the safety of Zandu Nityam Tablet & Zandu Nityam Churna in the patients suffering from Malavrodha w.s.r.t. functional constipation.
To compare the efficacy of Zandu Nityam Tablet with Zandu Nityam Churna
|Duration of study
6 Month
Period required for pre-trial preparation: 45 days
Period which may be needed for collecting the data: 3 months
Period that may be required for analyzing the data: 1 month
Period that may be required for submitting final report: 15 days
|Sample size
Total 60 complete cases
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of Functional constipation, fulfilling diagnostic criteria of ROME III criteria for functional constipation, Patients irrespective of sex, caste and religion, patients willing to provide informed consent.
排除标准
- •Patients not fulfilling the diagnostic criteria.
- •Pregnant and lactating women Patients of other gastro-intestinal diseases like IBS etc.
- •patients having life threatening disorders like malignancies, renal failure, cardiac failure.
结局指标
主要结局
1.Zandu Nityam Tablet is non-inferior to Zandu Nityam Churna in improving bowel movement frequency and stool consistency
时间窗: 6 months | Period required for pre-trial preparation: 45 | Period which may be needed for collecting the data: 3 months | period that may be required for analyzing the data: 1 month | period that may be required for submitting final report: 15 days
2. Zandu Nityam Tablet has a comparable safety profile to Zandu Nityam Churna
时间窗: 6 months | Period required for pre-trial preparation: 45 | Period which may be needed for collecting the data: 3 months | period that may be required for analyzing the data: 1 month | period that may be required for submitting final report: 15 days
次要结局
- Assessment of patient satisfaction with the treatment, including ease of use, preference for tablets vs. churna, and perceived effectiveness.(6 months)
研究者
Dr. Pragati Ashok Katariya
Shri Dhanwantry Ayurvedic college and hospital, Chandigarh