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CTRI Number  CTRI/2022/05/042602 [Registered on: 17/05/2022] Trial Registered Prospectively
Last Modified On: 12/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized Factorial Trial 
Public Title of Study   Use of Kalajaji and Rasna churna with Basti and yogic practices in primary dysmenorrhoea (kashtartava)  
Scientific Title of Study   A comparative study on effect of Kalajaji and Rasna churna along with Basti and selected yogic practices in primary dysmenorrhoea (kashtartava) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SUNITA SUMAN 
Designation  PROFESSOR 
Affiliation  INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY 
Address  DEPARTMENT OF PRASUTI TANTRA EVAM STREE ROGA FACULTY OF AYURVEDA INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY VARANASI

Varanasi
UTTAR PRADESH
221005
India 
Phone  7607165096  
Fax    
Email  ssom18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SUNITA SUMAN 
Designation  PROFESSOR 
Affiliation  INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY 
Address  DEPARTMENT OF PRASUTI TANTRA EVAM STREE ROGA FACULTY OF AYURVEDA INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY VARANASI

Varanasi
UTTAR PRADESH
221005
India 
Phone  7607165096  
Fax    
Email  ssom18@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR POONAM PRAJAPATI 
Designation  JUNIOR RESIDENT 
Affiliation  INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY 
Address  DEPARTMENT OF PRASUTI TANTRA EVAM STREE ROGA FACULTY OF AYURVEDA INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY VARANASI
OPD NO 24 SIR SUNDARLAL HOSPITAL, FACULTY OF AYURVEDA, INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY VARANASI
Varanasi
UTTAR PRADESH
221005
India 
Phone  8948083796  
Fax    
Email  poonam0811h@gmail.com  
 
Source of Monetary or Material Support  
FACULTY OF AYURVEDA, INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY, VARANASI 
 
Primary Sponsor  
Name  FACULTY OF AYURVEDA INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY 
Address  DEPARTMENT OF PRASUTI TANTRA, FACULTY OF AYURVEDA, INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SUNITA SUMAN  SIR SUNDAR LAL HOSPITAL,BANARAS HINDU UNIVERSITY  PRASUTI TANTRA OPD NO 24 AND IPD OF DEPARTMENT OF PRASUTI TANTRA FACULTY OF AYURVEDA IMS BHU VARANASI UTTAR PRADESH
Varanasi
UTTAR PRADESH 
7607165096

ssom18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N00-N99||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,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charak sidhhi sthana 1/40, Procedure details: Purva karma (Pre Basti Procedure): • Procedurewill be explained to patient and informed consent will be taken. • Patients will be called for Bastitherapy 10 days prior to expected date of menses, patients was advised to take light diet in last night. • Before giving Basti,patients will be examined and her vitals i.e. B.P., Temperature, respiratory rate and pulse rate will be checked and noted. • Full aseptic precaution will be taken for Basti. • Patient will be asked to lie down )
(1) Medicine Name: Rasna churna, Reference: charak sutra sthana 25/40, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Duration: 90 Days
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  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.
 
 
ExclusionCriteria 
Details  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.ï‚§ 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.


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/05/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 mlkalajajitaila) 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 mlRasnataila) 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).

 
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