A clinical trial to study the effect of Lekhaniya Mahakashaya Yoga Basti And Apamarga Kshara Taila Uttara Basti along with Rasanadi Ksheerpaka in the management of adenomyosis

Phase 2/3

Not yet recruiting

• Conditions: Chronic inflammatory disease of uterus. Ayurveda Condition: ARTAVAVAHA-SROTODUSHTIH,

• Registration Number: CTRI/2023/05/052788
• Lead Sponsor: National Institute Of Ayurveda

Brief Summary

PRIMARY PURPOSE-Treatment   

NEED OF THE STUDY: The incidence of adenomyosis is under discussion since different imaging criteria are used.

Prevalence of adenomyosis is 9% in healthy individuals, but in case of those suffering from

endometriosis the prevalence is 70%. Discrete and diffuse patterns of adenomyosis are found

in 54% of young women with infertility and dysmenorrhea or menorrhagia.6 Nationally, the

prevalence is found to be 23.5% in patients who had complain of menorrhagia(70.4%),

followed by dysmenorrhea (35.6%).

7

Although adenomyosis has always been considered a disease of multiparous women-over 40

years old who have pain and heavy bleeding, diagnosed on hysterectomy, now the

epidemiological scenario has completely changed. Over the last decade, adenomyosis has

become a condition identified in young women with pain,AUB ,infertility, or no symptoms

by using imaging techniques and hysterectomy cannot be the line of treatment .Even

available medical management like hormonal therapy is not effective in treating the disease

and the complications include infertility, post partum hemorrhage and even endometrial

carcinoma in rare cases.

As the incidence of adenomyosis is constantly increasing (23.5%), complications are severe

and there is no known cure for the condition in modern system of medicine .Ayurveda is

having a great scope of research in this field as well as contributing a better solution for the

problem. No any previous published scientific research work in academic level has been

reported on the ayurvedic management of adenomyosis. So interpreting the condition in

ayurvedic view as Mamsa dushti janya garbhashaya vikara, it may be possible to establish aneffective ayurvedic treatment protocol for the managementof adenomyosis and reversing the

pathology for getting a permanent cure which is challenge for the ayurveda gynecology

practitioners.

In view of this Effect of Lekhaniya Mahakashaya Yoga Basti And Apamarga Kshara Taila

Uttara Basti Along With Rasanadi Ksheerpaka In The Management Of Adenomyosis- are

selected as trial drugs as to provide an easy and cost effective therapeutic measures for

adenomyosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-07
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

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

Inclusion Criteria

• Patients willing to give voluntary informed consent.
• 2.Married women of age group between 21-45 yrs.
• 3.Patients having any two complaints either menorrhagia, dysmenorrhea,dyspareunia, or infertility and diagnosis of adenomyosis confirmed by TVS or any other diagnostic techniques.
• 4.Patients who are yogya for basti and Uttara basti.

Exclusion Criteria

• 1.Pregnant woman.
• 2.Patient having any systemic diseases like Diabetes (FBS>126mg/dl), Hypertension (>140/100 mmHg), severe anaemia (Hb <7%).
• 3.Congenital anomaly of reproductive tract.
• 4.Patient having any type of malignancy.
• Acute inflammatory disease like Acute PID & Sexually Transmitted Diseases like HIV, VDRL,HBsAg,HCV positive females.
• 6.Patient using oral contraceptive pills and Intra Uterine Contraceptive Devices.
• 7.Patient with thyroid hormone abnormalities.
• 8.Patients Ayogya (contraindicated) and not willing for Basti and Uttara basti.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Changes in the clinical features (interval between two menstrual cycle , duration of menstrual bleeding ,quantity of menstrual bleeding , pain during menses , dyspareunia and infertility ) and assess adenomyotic changes in uterus (adenomyotic foci either focal or diffuse, Location, cystic changes, uterine layer involvement ,uterine volume ,endometrial thickness of uterus).	90 DAYS

Secondary Outcome Measures

Name	Time	Method
1. Changes in quality of life (WHOQOL-BREF SCALE).	90 DAYS

Trial Locations

Locations (1)

National Institute of ayurveda (DEEMED TO BE UNIVERSITY)jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute of ayurveda (DEEMED TO BE UNIVERSITY)jaipur

🇮🇳Jaipur, RAJASTHAN, India

Deepika Munjal

Principal investigator

8440017435

munjudeepika@gmail.com