| CTRI Number |
CTRI/2021/06/033932 [Registered on: 01/06/2021] Trial Registered Prospectively |
| Last Modified On: |
29/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of Rajaswalacharya
On different patterns of menstrual cycle
|
|
Scientific Title of Study
|
Role of Rajaswalacharya on different patterns of menstrual cycle
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hetal H Dave |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
PG department of Prasuti Stri Roga National Institute of Ayurveda near jorawar singh gate Amer road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9251758867 |
| Fax |
|
| Email |
hetaldave2406@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hetal H Dave |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
PG department of Prasuti Stri Roga National Institute of Ayurveda near jorawar singh gate Amer road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9251758867 |
| Fax |
|
| Email |
hetaldave2406@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bharathi Kumaramanglam |
| Designation |
Professor and HOD |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG department of Prasuti Stri Roga National Institute of Ayurveda near jorawar singh gate Amer road
Jaipur
RAJASTHAN
302002
India |
| Phone |
09492047131 |
| Fax |
|
| Email |
baruhunt@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Near Jorawar Singh gate Amer road Jaipur Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
PG deptt of prasuti stri roga national institute of Ayurveda near jorawar singh gate amer road jaipur |
| 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 |
| Hetal H Dave |
National Insitute Of Ayurveda |
PG department of Prasuti Stri Roga National Institute of Ayurveda near jorawar singh gate Amer road
Jaipur
RAJASTHAN |
9251758867
hetaldave2406@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instititional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: ARTAVAVAHASROTOVIKARAH, (2) ICD-10 Condition: N921||Excessive and frequent menstruation with irregular cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Placebo
Dose: 1 capsule of Mishri 500 mg
Frequency: twise a day
Route: oral |
| Intervention |
Rajaswalacharya |
A diet regime of Shali rice, Yava (Barley), Ghee, Milk
Route: Oral
Frequency: OD
Dose: Three time a day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Subjects of age group 18 to 45 years complaining of chief complaint of dysmenorhoea/ abnormal uterine bleeding (AUB)/ oligomenorrhoea.
2. Subjects suffering with dysmenorhoea/ abnormal uterine bleeding (AUB)/ oligomenorrhoea for 2 consecutive cycles.
For Group - A: dysmenorhoea with scanty or average amount of menses
For Group - B: Heavy menstrual bleeding (amount >80ml) or
Prolonged menstrual bleeding (duration >7 days) or
Frequent menstrual cycle (interval< 21 days)
For Group C - Oligomenorrhoea: Interval between 2 cycle exceeding more than 35 days but not more than 50 days
|
|
| ExclusionCriteria |
| Details |
1. Subjects suffering from venereal diseases.
2. Subjects suffering from systemic diseases.
3. Subjects having organic pathology of uterus and adnexae eg. Fibroid uterus - size of fibroid less than 2 cm.
4. Subjects using intra uterine contraceptive devices.
5. Subjects with H/O hypothyroidism and hyperthyroidism with DUB.
6. Pregnant women.
7. Patients having bleeding due to abortion.
8. Patients having bleeding after menopause.
9. Patients having coagulation disorders.
10. Any type of malignancy.
11. Drug induced amenorrhoea/oligomenorrhoea/ abnormal uterine bleeding (AUB)
12. Patients taking OCPs
13. Patient having congenital and structural abnormality of uterus.
14. Haemoglobin less than 9 gm%.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check the effectiveness of Rajaswala charya in the management of different patterns of menstrual cycle |
20 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To develop standard protocol of Rajaswala charya.
2 To conduct a survey of the prevalence and incidence of different patterns of menstrual cycle.
|
20 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/06/2021 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
- Subjects of age group 18 to 45 years complaining of chief complaint of dysmenorhoea/ abnormal uterine bleeding (AUB)/ oligomenorrhoea.
- Subjects suffering with dysmenorhoea/ abnormal uterine bleeding (AUB)/ oligomenorrhoea for 2 consecutive cycles.
For Group - A: dysmenorhoea with scanty or average amount of menses For Group - B: Heavy menstrual bleeding (amount >80ml) or Prolonged menstrual bleeding (duration >7 days) or Frequent menstrual cycle (interval< 21 days) For Group C - Oligomenorrhoea: Interval between 2 cycle exceeding more than 35 days but not more than 50 days |