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 |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
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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 |
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Source of Monetary or Material Support
|
FACULTY OF AYURVEDA, INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY, VARANASI |
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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
|
|
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 |
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Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTE ETHICAL COMMITTEE |
Approved |
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Regulatory Clearance Status from DCGI
|
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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, |
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Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•रà¥à¤®/वसà¥à¤¤à¤¿à¤•रà¥à¤® | (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 |
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Inclusion Criteria
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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.
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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.
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Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
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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) |
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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 |
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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
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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). |