A Clinical trial to study of Jyotishmatyadi churna and matra basti of Satpushpa tail in patients of Artavakshaya w.s.r. Oligo-Hypomenorhhea.

Phase 2

Not yet recruiting

• Conditions: Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH,

• Registration Number: CTRI/2022/10/046184
• Lead Sponsor: State Ayurvedic College and Hospital Lucknow

Brief Summary

**The study is entitled as** – “A comparative clinicalstudy to evaluate the effect Jyotishmatyadi churna

alongwith Satpushpataila Matra Basti in the management of Artavakshaya w.s.r.Oligo-Hypomenorrheaâ€.

 **Objective of study** – To compare the efficacy ofJyotishmatyadi churna and Jyotishmatyadi churna

alongwith Satpushpa taila Matra Basti in the management ofArtavakshaya w.s.r. Oligo-Hypomenorrhea.

 **Type of study** – Randomized comparative open clinicaltrial.

 **Administration of trial therapy –** Minimum 40 patienthaving cardinal symptoms of Artavakshaya will

registered into groups.

 **Group A** – Jyotishmatyadi churna ( 3 gm ) twice a daywith milk after meal ( after clearance of menses ).

 **Group B** – Jyotishmatyadi churna ( 3 gm ) twice a daywith milk after milk and Satpushpa taila Matra

Basti ( 60 ml ) once in a day for 9 days ( after clearanceof menses ).

 **Duration of period** – 3 consecutive cycles ( 2 cycleswith trial drug and one cycle drug free follow up ).

 **Therapy period** – 2 consecutive cycles after clearanceof menses.

**Follow up during treatment** – On the clearance of eachmenstrual cycle during the period of treatment.

 **Criteria for selection of patient -**

**Diagnostic criteria** –   Diagnosis will be based on the presence of anyone or more of the cardinal symptoms of Artavakshaya.

A.     **Yathochitakala Adarshanam of Artava** –Menstrual cycle > 35 days

B.     **Alpartavam** –

1.      Duration of bleeding < 2 days

2.      Decrease in quantity of Bleeding

**C.****Yoni Vedana**

**Inclusion criteria –**

 1.    1  . Patients between age group of 18 – 40 years.

2.     2 . Patients fulfilling the cardinal symptoms ofArtavakshaya.

3.     3 . Patients willing to participate in the studywith proper written consent.

 **Exclusion criteria –**

 1.      Patient having systemic disease (HTN, TB , DM )

2.      Thyroid disorder

3.      Pregnant and Lactating women

4.      Patient on 0CPs , IUCD

5.      Congenital anomalies of uterus or ovaries

6.      Patient with any pelvic pathology or malignancy

7.      PCOD

8.      Hb% less than 10 gm

 **Investigation** – At the time of registration.

 1.      Hb%

2.      ESR

3.      FBS

4.      LFT

5.      Thyroid profile

6.      USG – Pelvic region ( Endometrial thickness )

7.      UPT

 **Assessment criteria** – Assessment will be done on the basis of improvement in the sign andsymptoms

for the purpose.

**Subjective criteria** –

1.      Interval between two cycles

2.      Duration of bleeding

3.      Amount of blood loss

4.      Pain during menstruation – assess with the helpof VAS scale

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-09-16
• Study Start: 2022-10-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• 1- Patients between the age group of 18-40 years.
• 2- patients fulfilling cardinal symptoms of Artavakshaya.
• 3- patients willing to participate in the study with proper written consent.

Exclusion Criteria

1- patient having systemic diseases(HTN,TB,DM) 2- Thyroid disorder 3- Pregnant & lactating women 4- patient onOCPs,IUCD 5- Congenital anomalies of uterus or ovaries 6- Patient with any pelvic pathology or malignancy 7- PCOD 8- Hb% less than 10 gm.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1- To assess the efficacy of Jyotishmatyadi churna along with satpushpa taila Matra Basti inthe management of Artavakshaya.	3 consecutive cycle (2 cycle with trial drug and one cycle drug free follow up.
2- To assess the efficacy of trial therapy on subjective parameters like interval between two cycle,duration of bleeding,amount of blood loss and pain during menstruation- assess with the help of VAS scale.	3 consecutive cycle (2 cycle with trial drug and one cycle drug free follow up.

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of trial therapy on subjective parameters like interval between two cycles,duration of bleeding,amount of blood loss and pain during Menstruation- assess with the help of VAS scale.	3 consecutive cycles (2 cycles with trial drug and one cycle drug free follow up ).

Trial Locations

Locations (1)

State Ayurvedic College and Hospital Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

State Ayurvedic College and Hospital Lucknow

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Gyan jyoti Chaudhary

Principal investigator

9140798293

singhjyoti1483@gmail.com