A comparative clinical study of dantyadi gutika along with yoga intervention in the management of scanty and delayed menses.

Phase 2

Completed

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

• Registration Number: CTRI/2021/03/031891
• Lead Sponsor: State Ayurvedic college and Hospital Lucknow

Brief Summary

**The study is entitled as - "**A comparative clinical study of dantyadi gutika aling with yoga intervention in the management of artavkshaya w.s.r. oligo-hypomenorhhoea".

**Objective of study**- To compare the efficacy of *Dantyadi Gutika* and *Dantyadi gutika* along with *Yoga Intervention* in the Management of *Artavakshaya* w.s.r. to Oligo-Hypomenorhhoea.

**Type of study**- Randomized comparative open clinical trial.

**Administration of trial therapy -**Minimum 40 patients having cardinal symptoms of artavkshaya  will be registered into two groups.

Group A -  two tablet of Dantyadi gutika (500 mg each) twice a day with plain water.

Group B –  two tablet of Dantyadi gutika (500 mg each) twice a day with plain water & Yoga Intervention.

The duration (30 min) of *Yoga* session will be as follow-

Loosening (*Shithalikaran vyayam)***-** 5 min

*Asana(Bhadrasana*,*Gomukhasana*,*Dhanurasana*,*Bhujangasana*,*Paschimottanasana)**-***15 min

*Pranayama **-*** 5 min

*Shavasana **-*** 5 min.

**Duration of trial-**4 consecutive cycles.

**Therapy period-**3 consecutive cycles with gap of 5 day from the start of menstruation.

**Follow up during treatment-**On the clearance of each menstrual cycle.

**Drug free follow up-**On the clearance of next menstrual cycle after completion of trial.

**CRITERIA FOR SELECTION OF PATIENT**

**Diagnostic Criteria**

Diagnosis will be based on the presence of the cardinal symptom of *Artavakshaya*.

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

B. *Alpartavam* – a) Duration of bleeding < 2 days

b) Decrease in quantity of bleeding (using pad per day 2)

C. *Yoni* *Vedana* - Pain during menstruation.

**Inclusion criteria:**

1. Patients fulfilling cardinal symptoms of *Artavakshaya.*

2. Patients between the age group of 18-40 years.

3. Patients willing to participate in the study with proper written consent.

**Exclusion criteria:**

1. Patient having systemic diseases which interfere with the present study(HTN,TB, DM, Thyroid disorder and Hyperprolactenamia.

2. Pregnant & Lactating women.

3. Patient on OCPs, IUCD.

4. Congenital anomalies of uterus or ovaries.

5. Patient with any pelvic pathology or malignancy.

6. Hb% less than 8 gm%.

**OUTCOME ASSESMENT** : Assessment will be done on the basis of improvement in the sign and symptoms before and after trial through scoring pattern. Subjective Criteria are Interval between two cycles, Duration of Bleeding, Amount of blood loss, Grade of pain – assess with the help of VAS scale and the Objective Criteria are Hb%, ESR, LFT, USG.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-15
• Study Completion: 2022-04-22
• Last Update Posted: 2022-09-17

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• 1.Patient having systemic diseases which interfere with the present study(HTN,TB, DM, Thyroid disorder and Hyperprolactenamia) 2.Pregnant & Lactating women.
• 3.Patient on OCPs, IUCD.
• 4.Congenital anomalies of uterus or ovaries.
• 5.Patient with any pelvic pathology or malignancy.
• 6.Hb% less than 8 gm%.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess the efficacy of Dantyadi gutika along with Yoga Intervention in the Management of Artavakshaya.	Final assessment will be done after completion of trial of 4 consecutive menstrual cycles.
2. To assess the efficacy of trial therapy on subjective parameters like Interval between two cycles, Duration of Bleeding, Amount of blood loss, Grade of pain – assess with the help of VAS scale and Objective parameters like Hb%, ESR, LFT, USG.	Final assessment will be done after completion of trial of 4 consecutive menstrual cycles.

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, Grade of pain – assess with the help of VAS scale.	follow up - each menstrual cycle after the clearance of menses during trial.

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 Simran

Principal investigator

7974926877

simmi00.sk@gmail.com