Use of Kalajaji and Rasna churna with Basti and yogic practices in primary dysmenorrhoea (kashtartava)

Not yet recruiting

• Conditions: Diseases of the genitourinary system. Ayurveda Condition: Disease of genitourinary system, (2) ICD-10 Condition: N944||Primary dysmenorrhea. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, (3) ICD-10 Condition: N944||Primary dysmenorrhea. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH,

• Registration Number: CTRI/2022/05/042602
• Lead Sponsor: FACULTY OF AYURVEDA INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY

Brief Summary

In today scenario disorder of menstruation is the commonest amongst all the gynecological complaints, which have a direct effect on the physical as well as physiological health of the female, Primary Dysmenorrhoea is described as painful menstruation of sufficient magnitude so as to incapacitate the day to day activities. The pain is spasmodic and confined to lower abdomen, may radiate to back and medial aspect of thighs. It may be associated with systemic discomforts like nausea, vomiting, fatigue, diarrhoea, headache and tachycardia. Oral use of kalajaji and rasna churna along with basti with specific yogic practices are one of them which are specific treatment in gynecological and menstrual disorder.All the registered patients will be divided randomly in two trial groups A and B, Group A will be treated with *Kalajajichurna* (6 gm, in two divided dose) for duration of 90 days +*AsthapanaBasti* (240ml = 180 ml *kalajajikwatha*+ 60 ml *kalajajitaila*) and *AnuvasanaBasti*(60 ml*kalajajitaila*) 10 days prior to expected date of menses for 3 consecutive cycle + *YogicPractices (*60 min.), Group B will be treated with *Rasnachurna* (6 gm, in two divided dose) for duration of 90 days + *AsthapanaBasti* (240 ml = 180 ml *Rasnakwatha*+ 60 ml *Rasnataila*) and *AnuvasanaBasti*(60 ml*Rasnataila)* 10 days prior to expected date of menses for 3 consecutive cycle + *YogicPractices*(60 min.)for 4 consecutive cycles, Total 4 follow up will be done at regular interval of one month before 10 days prior to expected date of menses,three (3) follow ups will be done with medication and one (1) follow up without medication to see the change in parameters , assessment will be done on the basis of prepared proforma or subjective and objective parameters including improvement in sign and symptoms of kashtartava (primary dysmenorrhoea).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-21
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Patients willing to participate in study.
• Age group between 14 to 45 years,(11 to 13 years of age girls will not be the part of research work because of fear of therapies in them).
• Unmarried and married both patients attending the OPD with chief complain of Primary Dysmenorrhea (kashtartava) with scanty or average amount of menses along with associated symptoms without any organic pathology.
• Patients suffering for more than two cycles.

Exclusion Criteria

• 1.Patients below 14 years and above 45 years.
• Any abnormalities detected in investigation (routine and specific).
• 2.Coagulation disorders.
• 3.Patients suffering from chronic systemic disease like uncontrollable diabetes, uncontrollable hypertension, venereal disease, thyroid dysfunction, renal diseases, jaundice or any disorder influencing general physical health and ultimately influencing menses.
• 4.Patients using IUCD & OCPs or injectables contraceptives & others.
• 5.Patients with any history of allergy or allergy from trial drugs.
• 6.Patients having Central nervous system disorders like epilepsy, meningitis, migraine or any other psychological disorders.
• 7.Patients having Respiratory disorders like bronchial asthma, tuberculosis, pneumonia, pleural effusion, bronchitis & others.
• 8.Patients suffering from cardiac disorders like angina, myocardial infarction, congenital anomalies of heart & others.Patients having gastrointestinal disoders like appendicitis, cholecystitis, hepatitis, pancreatitis, cholelithiasis, diverticulutis, gastric ulcer, irritable bowel syndrome & others.
• 9.Patients having organic pelvic pathology, benign and malignant tumors of vulva, vagina, rectum, cervix, uterus, PID, congenital anomalies of genital tract and different type of infections of genital tract.
• 10.Patient having breast carcinoma.
• 11.Patient is on chemotherapy/radio therapy for any malignant condition of any organ.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment will be done on the basis of prepared proforma and improvement in sign and symptoms of kashtartava	4 month (3 month with medication and 1 month without medication)

Secondary Outcome Measures

Name	Time	Method
Improvement in criteria listed in different scales	Total four (4) follow-ups will be done at regular interval of one month before 10 days prior to expected date of menses for 4 consecutive cycles, Three (3) follow ups will be done with medication and one (1) without medication to see the changes in parameters

Trial Locations

Locations (1)

SIR SUNDAR LAL HOSPITAL,BANARAS HINDU UNIVERSITY; 🇮🇳 Varanasi, UTTAR PRADESH, India

SIR SUNDAR LAL HOSPITAL,BANARAS HINDU UNIVERSITY

🇮🇳Varanasi, UTTAR PRADESH, India

DR SUNITA SUMAN

Principal investigator

7607165096

ssom18@gmail.com