| CTRI Number |
CTRI/2022/02/039967 [Registered on: 02/02/2022] Trial Registered Prospectively |
| Last Modified On: |
12/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL TRIAL ON AYURVEDIC PANCHAKARMA
THEREPY IN EXESSIVE MENSTRUAL FLOW
|
|
Scientific Title of Study
|
A comparative clinical study of Virechana Karma
and Drakshadi churna along with Matra Basti in
the management of Asrigdara w.s.r. to 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 |
Manju Meena |
| Designation |
PG Student |
| Affiliation |
National institute of Ayurveda Jaipur Rajasthan |
| Address |
Department of Prasuti Tantra avum Stri Roga, National Institute of
Ayurveda, Near Jorawar singh gate, Amer road,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414770823 |
| Fax |
|
| Email |
manjurajalwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hetal H Dave |
| Designation |
Associate Professor |
| Affiliation |
National institute of Ayurveda Jaipur Rajasthan |
| Address |
Department of parasuti avum striroga NIA,near Jorawar Singh Gate, Amer Road , Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9251758867 |
| Fax |
|
| Email |
hetaldave2406@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hetal H Dave |
| Designation |
Associate Professor |
| Affiliation |
National institute of Ayurveda Jaipur Rajasthan |
| Address |
Department of Prasuti Tantra avum Stri Roga, National Institute of
Ayurveda, Near Jorawar singh gate, Amer road,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9251758867 |
| Fax |
|
| Email |
hetaldave2406@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayuveda |
|
|
Primary Sponsor
|
| Name |
National institute of Ayurveda Jaipur Rajasthan |
| Address |
Department of Prasuti Tantra Avum striroga NIA Jorawar singh gate Amer road Jaipur Rajasthan |
| 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 Hetal H dave |
National Institute of ayurveda |
Department of prasuti avum striroga National institute of ayurveda Jaipur
Jaipur
RAJASTHAN |
9414770823
manjurajalwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Drakshadi churna along with matra basti |
Group B :-( comparator drug)
Will be treated by Matra basti with Dashmool taila along with Drakshadi Churna.
Dose- 60 ml
Drug route and method of administration:-Through Rectal route as per the SOP of Matra basti administration of the P.G. Department of Panchakarma. NIA, Jaipur.
Time of administration :- Late noon (immediately after meal-Aardrapani)
Treatment Period: 7 alternate days
Drakshadi Churna in the dose of 3gm two times a day with water before meal will be given immediately after completion of menstrual bleeding for 2 months.
Matra basti (60 ml) will be given on 10th day of menstrual cycle for 7alternate days.
|
| Intervention |
Virechana karma along Drakshadi churna and Matra basti |
Group A(Investigator Drug):
Will be treated by Virechana with Trivritalehya along with matra basti and Drakshadi Churna.
Dose- 30-80 gm for one day(acc. to kostha and agni bala)
Drug Route and method administration:- Through Oral route as per the Standerd Operating Procedure(SOP ) of Virechana drug administration of the P.G. Department of the Panchakarma. NIA, Jaipur.
Time of administration : As per SOP
Treatment period:-22 days(apporax.)
Drakshadi Churna in the dose of 3 gm two times a day with water before meal will be given immediately after completion of Virechana Karma for 2 months.
Matra basti (60 ml) will be given on 10th day of menstrual cycle for 7 alternate days. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients complaining of Asrigdara having any two of
the following symptoms:
Heavy menstrual bleeding.
Prolonged menstrual bleeding.
Inter menstrual bleeding.
2.Hb level equal or more than 8 gm/dl
3.Age between 12 year to 50 years
|
|
| ExclusionCriteria |
| Details |
1. Pregnant woman
2. Patients having bleeding due to abortion.
3. Ectopic Pregnancy.
4. Patients having any systemic diseases.
5. Patients having coagulation disorders.
6. Patients having bleeding after menopause.
7. Any type of malignancy.
8. Patients having STDs.
9. Patients using IUCDs.
10.Thyroid hormones abnormalities
11.Uterine and pelvic pathology like -Polyps,
Endometrial T.B, Fibroid, Adenomyosis, PID etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Achievement of normal menstruation |
8 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in quality of life.
|
8 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/02/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Asrigdara is one of the highly prevalent gynecological problems among the females during their reproductive years. Asrigdara or abnormal uterine bleeding is of more concern, because excessive or prolonged bleeding may cause undue disruption of woman’s daily activities & affects woman’s health both physically and psychologically. The incidence rate of Asrigdara is increasing day by day, so if treatment is delayed this can lead to a worsen condition of the patient due to excessive blood loss. Various reports suggest that 30 to 50% of women in the reproductive age group suffer from excessive and irregular uterine bleeding by various causative factors. 28% of the female population consider their menstruation excessive and will plan their social activities around their menstrual cycle, and nearly 10% of employed women will need to take time off from their work because of excessive menstrual loss . 6 % of women aged between 25 to 44 years consult their GPs about excessive menstrual loss every year. Out of them 35 % referred to hospital 60 % will have a Hysterectomy in the next 5 years. Over 75000 hysterectomies are now carried out every year with 30 % of them carried out for menstrual disturbances alone. If Asrigdara is not treated properly, it can cause further bleeding complications like anemia, excessive bleeding can even cause death. . Looking into the pathogenesis of Asrigdara, it occurs due to vitiation of Pitta and Rakta. Due to Apana Vayu Vaigunya with Agnimandya, Rasa Dhatu didn’t formed properly and improper Rasa Dhatu leads to improper Rakta Dhatu formation. In other words, all seven Dhatus formed improperly. Along this, Upadhatu of Rasa i.e. Artava formation is also impaired. Thus, for the treatment of Asrigdara, the drug having the properties of Pittashamana, Vatanulomana, Raktasthapana, Raktasamgrahi, Agnidepana and Garbhashaya Balya etc. are used iii . So the drug which have capacity to break the pathogenesis, arrest the progression of disease, reduce risk of complications and relieve the symptoms should be used in Asrigdara. So there is a great scope of research to find out safe, potent, cost effective procedure from Ayurveda by addressing the root of the problem thereby improving the quality of life of woman. Virechana with trivrilleham because of its pittashodhan property and dashmool taila because of its Tridosha shaman,vatanulomana properties have been taken in the present study to rule out and compare their therapeutic efficacy in the management of asrigdara . Aacharya Bhavmishra has described Kutaki drug as kaphapittapaha, pittarecaka. iv These are the factors why the topic is being selected for the present study. |