A Clinical Trail on Ayurvedic formulation in the management of Abnormal Uterine Bleeding.

Phase 2

Not yet recruiting

Conditions: Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,

Registration Number: CTRI/2025/05/086477

Lead Sponsor: National Institute of Ayurveda

Brief Summary: **PRIMARY PURPOSE** - Treatment

**NEED OF THE STUDY** - One of the most common gynaecological issue affecting women during their reproductive year is Asrigdara. Asrigdara or Abnormal uterine bleeding is of more concern, because excessive or prolonged bleeding may cause undue disruption of woman’s daily activities & affects woman’s health both physically and psychologically. The incidence rate of Asrigdara is increasing day by day, so if treatment is delayed this can lead to a worsen condition of the patient due to excessive blood loss. According to FIGO, AUB is most common complaint in gynecology. It accounts for 70% of all gynecologic consults, affects 1/3 of women at some stage in their life. The estimated worldwide prevalence is about 4 to 52%. In India its prevalence is about 17.9%. If Asrigdara" is not treated properly, it can cause further complications like Daurbalya, Bhram, Paandu, anaemia, excessive bleeding can even cause death.

Various treatment modalities prescribed in modern medicine like hormonal treatment, anti-fibrinolytic agents, dilatation and curettage etc. have not proved their definite efficacy in spite of high price and side effects. Although the medical therapy is generally used first in which long term use of hormones like progestin may increase the risk of breast cancer. Dilatation and curettage can also stop the acute episode of excess uterine bleeding but not the subsequent episode, therefore the ultimate option for Menorrhagia is Hysterectomy. Morbidity is related with the amount of blood loss at the time of menstruation, which occasionally is severe enough to cause Hemorrhagic shock.

So, it is a great scope of research to find out safe, potent, cost effective remedy from Ayurveda by addressing the root of the problem thereby improving the quality of life of woman. Looking into the pathogenesis of Asrigdara, it occurs due to vitiation of Pitta, Rakta and Apana Vayu Vaigunya. In Asrigdara due to loss of Rakta dhatu other dhatus also. decreased and they lead to Agnimandya". Due to Agnimandya, Rasa Dhatu didn’t form properly and improper Rasa Dhatu leads to improper Rakta Dhatu formation. In other words, all seven Dhatus formed improperly. Along this, Upadhatu of Rasa i.e. Artava formation is also impaired. Thus, for the treatment of Asrigdara, the drug having the properties of Pittashamana, Vatanulomana, Raktasthapana, Raktasamgrahi, Agnidepana and Garbhashaya Balya etc. are used. So the drug which have capacity to break the pathogenesis, arrest the progression of disease, reduce risk of complications and relieve the symptoms should be used in Asrigdara.

There is no research has been done on Mruttika chikitsa in management of Asrigdra till date. Mruttika is easily available and cost effective too. Our Aacharyas have told mruttika chikitsa in Asrigdara. That is why this will be the first research on mruttika chikitsa in Asrigdara which improve quality life of women

These are the factors why the topic is being selected for the present study.

**HYPOTHESIS**

**Null hypothesis [Ho1**]: Madhuyashti-Arjuna Ksheerpaka & Drakshadi churna along with Dashmoola taila matra basti will be equally effective in Asrigdara w.s.r to Abnormal Uterine Bleeding.

**[Ho2**]: Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti with and without mruttika chikitsa will be equally effective in Asrigdara w.s.r to Abnormal Uterine Bleeding.

**Alternate hypothesis [HAI]**: Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti will be more effective than Drakshadi churna along with Dashmoola taila matra basti and vice-versa in Asrigdara w.s.r to Abnormal Uterine Bleeding.

**[HA2]**: Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti with mruttika chikitsa is more effective than Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti in Asrigdara w.s.r to Abnormal Uterine Bleeding.

**RESEARCH QUESTION:**

1. Is there any difference in the efficacy of Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti and Drakshadi churna along with Dashmoola taila matra basti and vice-versa in Asrigdara w.s.r to Abnormal Uterine Bleeding?

2. Is there any difference in the efficacy of Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti with mruttika chikitsa and Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti in Asrigdara w.s.r to Abnormal Uterine Bleeding?

**AIM:**

To evaluate the effect of Yashtimadhu-Arjuna ksheerpaka in Asrigdara w.s.r. to AUB with and without Mruttika chikitsa.

**OBJECTIVES**

**Primary objectives:**

To assess the effect of Madhuyashti-Arjuna Ksheerpaka along with Dashmoola taila matra basti in Asrigdara w.s.r. to Abnormal Uterine Bleeding.

To assess the effect of Drakshadi churna along with Dashmoola taila matra basti in Asrigdara w.s.r. to Abnormal Uterine Bleeding.

To assess the effect of mruttika chikitsa in Asrigdara w.s.r. to Abnormal Uterine Bleeding.

To compare the effect of group A & B.

**Secondary objectives:**

To assess improvement in the quality of life (SF-36).

**Assessment Criteria**

All the patients registered for the present trial will be assessed by following parameters:-

PBLAC(Pictorial blood loss assessment chart)

SF-36 Questionnaire

Amount of menstrual blood

Prolonged menstrual bleeding.

Intermenstrual Period.

Generalized Body Ache.

Lower abdominal pain during menstruation.

Burning Sensation in lower abdomen, low back, pelvis, kidneys, abdomen or uterus. Generalized weakness.

**LABORATORY INVESTIGATIONS:**

**Before treatment**

Complete blood count (CBC).

Erythrocyte sedimentation rate (ESR).

Clotting time (CT).

Bleeding time (BT).

Prothrombin time (PT).

Blood sugar postprandial

Urine Routine and Microscopic examination.

TSH

**After treatment**

Complete blood count (CBC)

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 45

Inclusion Criteria

Patients presenting with any two of the following symptoms Heavy menstrual bleeding (amount more than 80ml) (PBLAC parameters) or Prolonged menstrual bleeding (With the duration of bleeding more than 7 days) or Inter menstrual bleeding Patients of age group 18 to 50 years.
Hb% equal to or more than 8gm/dl.

Exclusion Criteria

Pregnant women.
Patient having Post-menopausal bleeding.
Patients having bleeding due to abortion and childbirth.
Patients using Intra uterine contraceptive device.
Patient having any known case of coagulation disorders.
Patient having any known case of malignancy..
Patients having known case of STDs. Patients having any known case of systemic diseases.
Known case of Uterine and Pelvic pathology like- Polyps, Fibroid, Adenomyosis, Pelvic inflammatory disease.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achievement of Normal Menstruation.	2 months

Secondary Outcome Measures

Name	Time	Method
Improvement in quality of life.	2 months

Trial Locations

Locations (1): OPD and IPD of National Insitute of Ayurveda
🇮🇳
Jaipur, RAJASTHAN, India
OPD and IPD of National Insitute of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
Dr Dimpal chouhan
Principal investigator
8949455606
dimpalchouhanraj1996@gmail.com