| CTRI Number |
CTRI/2025/02/080339 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the effect of one Ayurvedic therapy in the treatment of Dysmenorrhea |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Sahachar Tail Matrabasti In The Management Of Udavartini Yonivyapad W.S.R. To Primary Dysmenorrhoea. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sneha Hargovind Karhade |
| Designation |
MS Prasutitantra Evam Streerog Scholar |
| Affiliation |
Matoshree Asarabai Darade Ayurved College Babhulgoan ,Yeola |
| Address |
OPD No.8 Department of Prasutitantra evum Streerog Matoshree Asarabai Darade Ayurved College Babhulgoan Tal- yeola Dist-Nashik Pin-423401 Maharashtra India
Nashik
MAHARASHTRA
423401
India |
| Phone |
7083012485 |
| Fax |
|
| Email |
snehakarhade04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipti Paithankar |
| Designation |
Associate Professor Prasutitantra evum Streerog Department |
| Affiliation |
Matoshree Asarabai Darade Ayurved College Babhulgoan ,Yeola |
| Address |
OPD No.8 Department of Prasutitantra evum Streerog Matoshree Asarabai Darade Ayurved College Babhulgoan Tal- yeola Dist-Nashik Pin-423401 Maharashtra India
Nashik
MAHARASHTRA
423401
India |
| Phone |
8668735193 |
| Fax |
|
| Email |
diptisonawane3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha Hargovind Karhade |
| Designation |
MS Prasutitantra Evam Streerog Scholar |
| Affiliation |
Matoshree Asarabai Darade Ayurved College Babhulgoan ,Yeola |
| Address |
OPD No.8 Department of Prasutitantra evum Streerog Matoshree Asarabai Darade Ayurved College Babhulgoan Tal- yeola Dist-Nashik Pin-423401 Maharashtra India
Nashik
MAHARASHTRA
423401
India |
| Phone |
7083012485 |
| Fax |
|
| Email |
snehakarhade04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prasutitantra Evum Streerog Matoshree Asrabai Darade Ayrved College Babhulgaon Tal- Yola Dist.-Nashik Pin-423401 |
|
|
Primary Sponsor
|
| Name |
Matoshree Asarabai Darade College Babhulgoan ,Yeola |
| Address |
Matoshree Asarabai Darade Ayurved College Babhulgao Tal- Yeola Dist-Nashik Maharashtra India Pin-423401 |
| 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 |
| DrSneha Hargovind Karhade |
Matoshri Asrabai Darade Ayurved College Babhulgao Yeola |
OPD No.8 Department of Prasutitantra evum Streeroga
Nashik
MAHARASHTRA |
7083012485
snehakarhade04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Matoshree Asarabai Darade Ayurved College Babhulgoan Yeola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: )
| | 2 | Comparator Arm | Procedure | - | bastikarma or vastikarma बस्तिकर्म or वस्तिकर्म Matrabasti मात्राबस्तिः | (Procedure Reference: Sushrutsamhita chikitsasthan 35 18, Procedure details: Purva Karma
Light meal advised to patient on the day of treatment Before administration of
Basti Abhyanaga with Tila Taila was done
Thereafter Nadi Sweda was performed
Pradhana karma
The patient was asked to lie down in the left lateral position with the left lower
extremity extended & the right lower extremity flexed at the knees and hips
Then 60 ml of lukewarm Trivruttadi tail was loaded in an enema syringe A rubber
catheter oileted with oil was attached to the enema syringe
After any air in the enema syringe had been expelled the rubber catheter was
passed through the anus of the patient up to a length of 4 inches and the drug was
administered The patient was asked to take deep breaths during the passage of
the catheter and the administration of the drug
Pashchath karma
After the administration of Basti the patient was advised assume the supine
position The patient was allowed to get up from the table and was then
advised to rest in bed for at least half an hour)
(1) Medicine Name: Trivruttadi taila, Reference: Ashtangsangraha 3 39 to 46, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1) Patients complaining of dysmenorrhea with regular menses with other associated
symptoms.
2) Patients of age group between 16 to 25 years
3) Symptoms of Udavartini yonivyapad (dysmenorrhea)for at least two regular
consecutive cycles.
4) Patient with UPT test negative.
5) Patients having Hemoglobin percentage more than 10 gm
6) Patients willing to participate |
|
| ExclusionCriteria |
| Details |
1) Patients of age below 16 and above 25 years.
2) Patients with major systemic diseases.
3) Patient on any medication of Dysmenorrhoea.
4) Patients having pelvic pathology.
5) Patients on hormonal therapy.
6) Hysteric patient.
7) Patients not willing to participate.
8) Patient with IUD |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Pain-Level,Duration
2)Nausea
3)Vomiting
4)Breast Tenderness
5)Headache |
1st day,3rd day ,5th day of 1st menstrual cycle
1st day ,3rd day,5th day of 2nd menstrual cycle
1st day,3rd day,5th day of 3rd menstrual cycle
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Above mentioned symptoms will be decreased |
3 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
21/02/2025 |
| 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="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In today’s era, sedentary life and stress are the inseparable part of modern life. The increased demand for the comfort, the women and adolescent girl has been loosing their health. It is obvious that an healthy women can produce an healthy generation but due to various gynaecological disorder this got failed. Dysmenorrhoea is a common and most challenging menstrual disorder which is faced by many women and adolescent girls during their reproductive phase and this leads to the discomfort in their day to day activity. Menstruation is a natural process that occur in every female in their reproductive phase. But in the modern era dysmenorrhoea is becoming an burning problem through the entire world. This also leads to anxiety and stress too. It causes discomfort in their day to day activity, this also leads to missing office work or school and sometime because of this one cannot participate in sports or any other activities. Ayurveda is an oldest science of healing. According to various acharya’s all Yoniroga which have been enlisted they cannot occur without the aggrivation of vata- .Among all Yonirogas there is one yonirog called Udavartini yonivyapad also called as kashtartava ,where pain is the main symptom which has strong relation with the vata. In text Udavartini yonivyapad is caused due to veg dharan of Purish ,mutra ,and vata because of these hetu the vata (apana vayu) gets viated and which become urdhwagami i.e/ the anuloman gati of apana vata get pratilom and that lifts the yoni(uterus) upward which leads to obstruction to the flow of raja(menstrual bleeding) and when raja comes out then there is relief from pain(2) . There is superior need to solve this problem which is faced by adolescent girls and many women. In ancient text of aacharya and literature there are various herbs which is describe in authentic manner for the management of kashtartava . In classic text there is reference of trivrutadi taila for Udavartini yonivyapad . Also in charak samhita there is reference of sahachar taila on the rajdosh vyadhi .Also ayurveda recommend diet modulation and yoga practice on daily basis for dysmenorrhoea. As per Aacharya yoniroga cannot occur without aggravation of vata and as basti is called as the ardha chikitsa of vata . Also as matra basti is conveniently used for treatment as being oil with its Sneha guna it act as shulaghana. 3 Need For Study :- Since the pain in dysmenorrhea results from dysrhythmic uterine constriction and uterine hypoxia, the effective treatment used in dysmenorrhea is Non steroidal anti inflammatory drug (NSAID’s). If pain dose not subsides with the treatment then oral contraceptives drug administered are useful in reliving dysmenorrhea. In ayurveda there are various treatment which are used for Udavartini yonivyapad . There is great scope to find out the management with long lasting effect and find out the treatment for underlaying pathology from the ancient text for management of Udavartini yonivyapad. As shaman chikitsa has effect for some duration and shodhan chikitsa has effect for longer duration in the treatment of the disease. and Basti is described as ardha chikitsa of the vata(5) and as explained in text sahachar sneha is indicated in rajovikar and sahachar acts by its ushna virya and vatkaphaghna karma .It can be used for primary dysmenorrhea without causing any adverse effect. |