Comparative Clinical validation study to assess the safety and efficacy of Unani pharmacopoeial formulation Qurs-e-Foh vs Hab e Mudir in Ehtebas-e-Tams (Amenorrhea)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- The safety and efficacy of Unani Pharmacopeial formulation Qurs-e-Foh in comparison with Hab e Mudir in Ehtabas-e-Tams (Amenorrhea) will be carried out on the basis of PBAC (Pictorial blood loss assessment chart) score.
研究概览
简要总结
This study is designed as a single centric, Randomized, Parallel Group, Active Controlled Trial in patients with Ehtabas-e-Tams (Amenorrhea) . After screening, the Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically for three consecutive menstrual cycles during the course of treatment. The subjective and objective clinical observations will be recorded in the follow-up sheet. The total duration of treatment will be 3 months. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Test formulation- Qurs-e-Foh
| S.No. |
Ingredients
Scientific Name
Quantity
|
Foh (Majeeth)
Rubia cordifolia Linn.
450 mg
|
Irsa
Iris ensata Thunb.
10 mg
|
Post-e-Bekh-e-Kabar
Capparis spinosa**Linn.
10 mg
|
Zarawand Taweel
Aristolochia rotunda Linn.
10 mg
|
Sikanjabeen
-
Q.S
Comparator formulation- Hab -e-Mudir
| S.No. |
Ingredients
Scientific Name
Quantity
|1.
Sibr
Aloe barbadensis Linn.
2 gm
|2.
Hira Kasees
Ferrous sulphate
1 gm
|3.
Zafran
Crocus sativus Linn.
1 gm
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients complaining of absence of menstruation for last 3 or more months.
- •Patients with secondary amenorrhoea.
排除标准
- •Patients with primary amenorrhea and primary ovarian failure
- •Patients with thyroid dysfunction, PCOD, hyperprolactinaemia
- •Patients with any systemic illness and malignancy
- •Pregnant and lactating woman
- •Patients with bleeding disorders
- •Patients taking Oral Contraceptive Pills(OCPs) /Intra- Uterine contraceptive devices (IUCDs).
结局指标
主要结局
The safety and efficacy of Unani Pharmacopeial formulation Qurs-e-Foh in comparison with Hab e Mudir in Ehtabas-e-Tams (Amenorrhea) will be carried out on the basis of PBAC (Pictorial blood loss assessment chart) score.
时间窗: At baseline, at the 1st follow-up (1st menstrual cycle), at the 2nd follow-up (2nd menstrual cycle), and at the 3rd follow-up (3rd menstrual cycle), i.e., 0 and three consecutive menstrual cycles. (The patient is advised to report 5 days prior to the expected date of the menstrual period)
次要结局
- Haematological and biochemical investigations for safety assessment i.e., Hemogram, LFT,KFT, Urine Examination: Routine & Microscopic.
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)