| CTRI Number |
CTRI/2021/04/032565 [Registered on: 06/04/2021] Trial Registered Prospectively |
| Last Modified On: |
05/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparative study between AYUSH LND ayurvedi formulation with standard drug in heavy and irregular menstrual bleeding |
|
Scientific Title of Study
|
A Comparative Clinical Study of AYUSH-LND a coded Ayurvedic Formulation in the Management of Asrigdara (Abnormal Uterine Bleeding) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashant Shinde |
| Designation |
Research officer |
| Affiliation |
Regional Ayurveda Research Institute for Mother and Child Health Nagpur |
| Address |
Near Gokul Parisar near NIT Complex Nandanvan
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9623011214 |
| Fax |
|
| Email |
drshindeprashant07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Shinde |
| Designation |
Research officer |
| Affiliation |
RARIMCH Nagpur |
| Address |
Regional Ayurveda Research Institute for Mother and Child Health Nagpur
Near Gokul Parisar near NIT Complex Nandanvan
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9623011214 |
| Fax |
|
| Email |
drshindeprashant07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Shinde |
| Designation |
Research officer |
| Affiliation |
RARIMCH Nagpur |
| Address |
Regional Ayurveda Research Institute for Mother and Child Health Nagpur
Near Gokul Parisar near NIT Complex Nandanvan
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9623011214 |
| Fax |
|
| Email |
drshindeprashant07@gmail.com |
|
|
Source of Monetary or Material Support
|
| INDIAN COUNCIL OF MEDICAL RESEARCH
|
|
|
Primary Sponsor
|
| Name |
INDIAN COUNCIL OF MEDICAL RESEARCH |
| Address |
V. Ramalingawami Bhawan, Ansari Nagar, Post Box Bo. 4911
New Delhi - 110029 |
| Type of Sponsor |
Research institution |
|
|
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 Prashant Raosaheb Shinde |
RARIMCH Nagpur |
OPD no. 3
RARIMCH GharkulParisar NIT Complex Nandanvan
Nagpur 440009
2 Govt Medical College
Nagpur Maharashtra
Nagpur
MAHARASHTRA |
9623011214
drshindeprashant07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee RARIMCH Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition:N859||Noninflammatory disorder of uterus, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, (2) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. tab AYUSH LND
2. Tablet IFA |
1. tab AYUSH LND2 tablets 3 times a day for 3 months with plain water after breakfast, lunch and dinner. 250 mg of Each tablet
2.Tablet IFA- 60mg Iron + 400 µg folic acid OD for 3 months |
| Comparator Agent |
1. Tablet Tranexamic acid
2. Tablet IFA |
1. Tablet Tranexamic acid- 500mg twice daily orally i.e. after breakfast and dinner with plain water for 7 days from 1st day of menses for three cycles
2. Tablet IFA One tablet (60mg Iron + 400 µg folic acid) once daily orally with plain water after breakfast |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Age between 18 to 35 years.
2. Women having complaint of excessive bleeding during menstruation by Pictorial blood loss assessment chart score more than 100 points or prolonged bleeding more than 7 days for 3 consecutive cycles
3. Willing and able to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Hb % < 7gm%.
2. Associated with reproductive system abnormalities (Excluded clinically and radiologically) Pelvic Inflammatory Disease, Cervicitis, Hydrosalpinx, Endometriosis, Adenomyosis, Fibroid Uterus, Carcinoma of Reproductive Organ etc.
3. Other causes of excessive menstrual bleeding e.g. Thyroid disease, Incomplete Abortion, abortion in last three months, IUCD.
4.Subjects on prolonged (> 6 weeks) drugs which can cause Abnormal Uterine Bleeding e.g. Anticoagulants, Acetylsalicylic acid, Antidepressants (Selective Serotonin Reuptake Inhibitors, Tricyclic Antidepressants), Hormone Replacement Therapy, Tamoxifen, Phenothiazines, Corticosteroids, Thyroxine, Oral Contraceptives, Herbs; Ginseng, Ginko-biloba, Soya products or any other drugs that may have an influence on the outcome of the study.
5. Lactating woman.
6. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
7. Patient with raised liver enzymes twice the upper limit of normal & creatinine more than 1.4 mg%, poorly controlled Hypertension (>160/100 mm of Hg), poorly controlled Diabetes Mellitus{B.S. (F) > 130 mg% and / or Blood Sugar (2 hr. PP) >250 mg% & HbA1c> 6.5%}.
8. Ingestion of any investigational drug within 4 weeks prior to recruitment in the study.
9. Patients who are currently participating in any other clinical trial or participated in past four weeks.
10. H/o hypersensitivity to the trial drug or any of its ingredients.
11. Any other condition which the Principal Investigator thinks may jeopardize the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the amount of uterine bleeding evaluated by Pictorial Blood Loss Assessment Chart or changes in the duration of bleeding or attainment of normal interval of cycles |
Baseline and end of every cycle up to Six cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Change in psychological general wellbeing index(PGWBI) |
Baseline, at the end of intervention period and follow-up visit |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applied |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Abnormal
Uterine Bleeding (AUB) is defined as any alteration in the pattern or volume of
menstrual blood flow. As per American College of Obstetrics & Gynaecology
Abnormal Uterine Bleeding (AUB) is occurred in conditions such as bleeding
between periods, bleeding after sex, spotting anytime in the menstrual cycle or
for more days than normal, bleeding after menopause. Menstrual cycles that are
longer than 35 days or shorter than 21 days are abnormal and it can occur at
any age. Abnormal Uterine Bleeding (AUB) can have many causes viz
miscarriage, ectopic pregnancy,
adenomyosis, use of some birth control methods such as an intrauterine device
(IUD) or birth control pills, infection
of the uterus or cervix, fibroids, problems with blood clotting, polyps,
endometrial hyperplasia, malignancy of the uterus, cervix, or vagina,
polycystic ovary syndrome1. AUB is reported to occur in 9 to 14% women between
menarche and menopause2. The prevalence varies in each country. In
India, the reported prevalence of AUB is around 17.9%3. The proposed drugs are in human use since long back and have no
side effects and are considered safer. A clinical study carried out on the
compound Ayurvedic herbal formulations Lodhrasava (30 ml thrice in a
day) and Pushyanuga churna (5 gm thrice a day) along with the Swarasa
(juice) of Durva (Cynodon dactylon (L.) given for three
consecutive cycles reported that these drugs are effective in controlling the
excessive bleeding and were found safe4. Clinical efficacy of these
trail drugs can be attributed mainly to the Lodhra
(Symplocos racemosa Roxb.) along with Durva (Cynodon dactylon
(L.) Pers.) and other astringent ingriedients of Pushyanuga churna like Jambu
(Syzygium cumini), Raktachandana (Pterocarpus santalinus), Kutaja (Holarrhena Antidysenterica), Dhataki (Woodfordia
fruiticosa), Manjista (Rubia cordifolia) etc. Another study reported by
Meena Parmar et al in 2014 showed the effectiveness of Pushyanuga churna,
Lodhra churna, Durva swarasa as a palliative management in Asrigdara
(Abnormal Uterine Bleeding)5.
|