A clinical trial on Ayurvedic formulation in the management of beejadushti janya stree vandhyatwa w.s.r. to Infertility due to anovulation.

Phase 2/3

Not yet recruiting

• Conditions: Female infertility associated withanovulation. Ayurveda Condition: VANDHYA,

• Registration Number: CTRI/2023/07/055219
• Lead Sponsor: National Institute of Ayurveda

Brief Summary

NEED OF STUDY:-In the present time *vandhyatwa* has been one of the unsolved major complaints of the couples. In allopathic system of medicine scope of medicinal treatment is very narrow. Hormonal therapy like- In vitro fertilization (IVF), Embryo transfer (ET), Gamete Intra fallopian transfer (GIFT) etc. So many therapies are developed but they have no satisfactory results. They are very expensive and have lots of side effects.On the other hand, Ayurveda offers a lots of potential for treating *stree vandhyatwa*. A number of studies have been carried out of drugs like - *Shatavari*, *Satpushpa*, *Kumari*, *Gokshur*, *Phalghrita*,*Brahmi ghrita*, *Pippliyadi churna*, *Dasmool kwath* etc. to determine their role in the treatment of*Vandhyatwa* .There are many such drugs mentioned in ayurveda classics heaving remarkable resultsin the management of *Vandhyatwa* which need to be studies further in detail. Amongst these drugs *Vatyapushpi beeja churna*, *Amogha churna* and *Ashwagandha ghrita* are choosen in this study. The properties of *Vatyapushpi beeja* is *prajasthapan, garbhasyaposhan, vrishya* and *vatasanshman*. Properties of *Amoga* is *prajasthapan, vatasansman* and properties of *Ashwagandha ghrita* is *dhatuvardhana, garbhasandhank, vrishya, rasayana, vatasanshman*. They are easily available, easy to administer, cost effective for the management of *beejaduhstijanya stree vandhyatwa*. So with all these considerations in mind the current study is undertaken.

**NULL HYPOTHESIS****:**There is no difference in the efficacy of oral administration of *Vatyapushpibeeja churna* with *Ashwagandha  ghrita* and *Amogha churna* with *Ashwagandha ghrita* in *Beejadushtijanya stree Vandhytwa.***ALTERNATIVE HYPOTHESIS****:-**There is  difference in efficacy of *Vatyapushpi beeja churna* with *Ashwagandha ghrita* and *Amogha churna* with *Ashwagandha ghrita* in management of *Beejadushtijanya stree Vandhytwa.***RESEARCH QUESTION:**-Is there any difference in the efficacy of *Vatyapushpi beeja  churna* with *Ashwagandha ghrita*and  *Amogha churna* with *Ashwagandha ghrita* in  management of *Beejadushtijanya stree Vandhytwa*? **AIM:-**To evaluate the efficacy of *Vatyapushpibeeja churna* and *Amogha churna* along with *Ashwagandha ghrita* orally in *Beejadushtijanya stree Vandhyatwa*.

**Primary** **objective:-**

To evaluate and  compare  the clinical  efficacy  of *Vatyapushpi beeja churna* and *Amogha  churna* along with  *Ashwagandha ghrita* to changes in the  anovulation and conception in the mangemant of *Beejdushti janya stree vandhyatwa*

**Secondary objective:-**

(1)   Changes in the duration and interval of menstrual cycle.

(2)   Prevalence of anovulation in different types of prakriti. **STUDY DESIGN:-**

1. **Study type–**Randomized clinical trial.2. **Masking–**Open label. 3. **Level of study–**OPD and IPD level.

5.**No of group–**Two groups.**Group A*****–****Vatyapushpi Beeja churna* with *Ashwagandha* ghrita. **GroupB*****–****Amogha churna* with *Ashwagandha* ghrita

6 **Samplesize–**15patient in each group. 6 **Primary purpose–**Treatment. 7 **Endpoint–**Efficacy. 8 **Method of generating randomization sequence –**Computer generated

**Primary Outcome**: 1. Changes in the anovulation 2. To achievement of the conception.

**Secondary Outcome**1. Changes in the duration and interval of menses. 2. Prevalance of anovulation in different type of Prakriti.

**INCLUSION CRITERIA****:**-

1. Anovulation (*beejadusti)* on folliculometry was verified in all cases of primary and Secondary *stree* *Vandhyatw*2. Age group between 21 to 40 yea 3. At least one fallopian tube must be patent.

**EXCLUSION CRITERIA**: 1. Congenital anatomical deformities of reproductive tract like bicornuate uterus,etc. 2. Bilateral tube blockage.3. Reproductive tract abnormalities i.e.-cervical stenosis, fibroid uterus, cervical polyp.4. Patient suffering from severe  infection and any systemic disorder like Tuberculosis,

Cardiacdisorder, DiabetesMellitus, Renal disorder, Bronchial Asthma.5. Patient suffering from HIV,VDRL.6. Infertility due to male partner abnormality.

**WITHDRAWAL CRITERIA:-**

1. During the course of trial if any serious condition   occurs that require urgent treatment.2. Non compliance and irregular follow up.3. Patient wants to withdraw from the clinical trial.

**INVESTIGATION:-****BEFORE TREATMENT**(1) Complete blood test–CBC.1) ESR–Erythrocytes Sedimentation rate.(2) Hepatitis B surface Antigen (HBsAg).

(3) HIV–Human Immuno deficiency Virus.(4) VDRL-Venereal disease research laboratory. (5) Thyroid function test (TFT),T3,T4,TSH. (6) Random blood sugar (RBS).

(7) Cervical mucus **(i)**Spinnbarkeit test **(ii)**Fern test. (8) USG–Uterus and adnexa & Follicular study. HSG–Hysterosalpingography

AFTER TREATMENT:-(1) Cervical mucus-**(a)** Spinnbarkeit test **(b)** Fern test(2) USG– Follicular study. 3) UPT-Urine pregnancy test if necessary.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-13
• Study Start: 2023-07-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Anovulation (beejadusti) on folliculometry was verified in all cases of primary and Secondary stree Vandhyatwa 2.
• Age group between 21 to 40 years 3.
• At least one fallopian tube must be patent.

Exclusion Criteria

• 1.Congenital anatomical deformities of reproductive tract like bicornuate uterus,etc.
• 2.Bilateral tube blockage.
• 3.Reproductive tract abnormalities i.e.-cervical stenosis, fibroid uterus, cervical polyp.
• 4.Patient suffering from severe infection and any systemic disorder like Tuberculosis, Cardiacdisorder, DiabetesMellitus, Renal disorder, Bronchial Asthma.
• Patient suffering from HIV,VDRL.
• Infertility due to male partner abnormality.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome:-1. Changes in the anovulation.	8 Weeks
2. To achievement of the conception.	8 Weeks

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome :-1. Changes in the duration & interval of menses.	2.Prevalance of anovulation in different type of Prakriti.

Trial Locations

Locations (1)

Opd and Ipd of Department of Prasuti tantra evam stree roga, National Institute of Ayurveda,Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Opd and Ipd of Department of Prasuti tantra evam stree roga, National Institute of Ayurveda,Jaipur

🇮🇳Jaipur, RAJASTHAN, India

Dr Suman Kumari

Principal investigator

9416375747

dr.sumanshagun@gmail.com