| CTRI Number |
CTRI/2023/05/052788 [Registered on: 17/05/2023] Trial Registered Prospectively |
| Last Modified On: |
16/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Lekhaniya Mahakashaya Yoga Basti And Apamarga Kshara Taila Uttara Basti along with Rasanadi Ksheerpaka in the management of adenomyosis |
|
Scientific Title of Study
|
Effect of lekhaniya mahakashaya yoga basti and apamarga Kshara taila uttara basti along with rasanadi Ksheerpaka in the management of adenomyosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poonam Choudhary |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of ayurveda |
| Address |
Room no.302 Third floor Department of Prasuti tantra evum stree roga National Institute Of Ayurveda,Jorawar singh gate,Amer road,jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9352311106 |
| Fax |
|
| Email |
poonam.18veena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Choudhary |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of ayurveda |
| Address |
Room no 302 third floor Department of Prasuti Tantra evum stree roga National Institute Of Ayurveda,Jorawar singh gate,Amer road,jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9352311106 |
| Fax |
|
| Email |
poonam.18veena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Choudhary |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of ayurveda |
| Address |
Room no 302 third floor Department of Prasuti Tantra evum stree roga National Institute Of Ayurveda,Jorawar singh gate,Amer road,jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9352311106 |
| Fax |
|
| Email |
poonam.18veena@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of ayurveda jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayurveda |
| Address |
Jorawar singh gate,amer road,jaipur |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Deepika Munjal |
National Institute of ayurveda (DEEMED TO BE UNIVERSITY)jaipur |
DEPARTMENT OF PRSUTI TANTRA EVAM STRIROGA,NATIONAL INSTITUTE OF AYURVEDA (DEEMED TO BE UNIVERSITY),JORAWAR SINGH GATE ,JAIPUR,RAJASTHAN-302002
JAIPUR
RAJASTHAN
302002
INDIA
Jaipur
RAJASTHAN |
8440017435
munjudeepika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N711||Chronic inflammatory disease of uterus. Ayurveda Condition: ARTAVAVAHA-SROTODUSHTIH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: CHARAKA SAMHITA , CHAKARADATTA , Procedure details: 15 patients will be treated with Uttara basti with Apamarga taila( before uttar basti 1 anuvasana and 1 aasthapana basti on alternative days )
Dose of Uttara basti drug - 5 ml Apamaraga ksharataila for uttara basti for 3 days in a cycle.
Drug Route: Uttara basti from vaginal route.
Time of administration: Uttara basti after food once in a day.
Treatment period: Uttara basti for 3 days continuously in a cycle (for 3 consecutive cycle),
)
(1) Medicine Name: RASANADI KSHEERPAKA , Reference: YOGARATNAKARA, Route: Oral, Dosage Form: Ksheerpaka, Dose: 40(ml), Frequency: bd, Duration: 90 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: CHARAKASAMHITA, Procedure details: 15 patients will be treated by Yoga Basti With Lekhaniya Mahakashaya
Dose of Anuvasana Basti- 60 ml (after food once in a day)
Dose of Aasthapana Basti – 400-500 ml(before food once in a day )
Drug Route: Anuvasana and aasthapana basti from anal route
Time of administration : Basti- started after cessation of menstruation for 8 days( first 2 anuvasana then aasthapana and anuvasana alternatively)
Treatment period:- 8 days in a month( for 3 consecutive cycle) ( yoga basti) )
(1) Medicine Name: RASANADI KSHEERPAKA, Reference: YOGA RATNAKARA, Route: Oral, Dosage Form: Ksheerpaka, Dose: 40(ml), Frequency: bd, Duration: 90 Days |
|
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients willing to give voluntary informed consent.
2.Married women of age group between 21-45 yrs.
3.Patients having any two complaints either menorrhagia, dysmenorrhea,dyspareunia, or infertility and diagnosis of adenomyosis confirmed by TVS or any other diagnostic techniques.
4.Patients who are yogya for basti and Uttara basti.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant woman.
2.Patient having any systemic diseases like Diabetes (FBS>126mg/dl), Hypertension (>140/100 mmHg), severe anaemia (Hb <7%).
3.Congenital anomaly of reproductive tract.
4.Patient having any type of malignancy.
5. Acute inflammatory disease like Acute PID & Sexually Transmitted Diseases like HIV, VDRL,HBsAg,HCV positive females.
6.Patient using oral contraceptive pills and Intra Uterine Contraceptive Devices.
7.Patient with thyroid hormone abnormalities.
8.Patients Ayogya (contraindicated) and not willing for Basti and Uttara basti.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Changes in the clinical features (interval between two menstrual cycle , duration of menstrual bleeding ,quantity of menstrual bleeding , pain during menses , dyspareunia and infertility ) and assess adenomyotic changes in uterus (adenomyotic foci either focal or diffuse, Location, cystic changes, uterine layer involvement ,uterine volume ,endometrial thickness of uterus). |
90 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Changes in quality of life (WHOQOL-BREF SCALE). |
90 DAYS |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2023 |
| 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="3"
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
|
PRIMARY PURPOSE-Treatment NEED OF THE STUDY: The incidence of adenomyosis is under discussion since different imaging criteria are used. Prevalence of adenomyosis is 9% in healthy individuals, but in case of those suffering from endometriosis the prevalence is 70%. Discrete and diffuse patterns of adenomyosis are found in 54% of young women with infertility and dysmenorrhea or menorrhagia.6 Nationally, the prevalence is found to be 23.5% in patients who had complain of menorrhagia(70.4%), followed by dysmenorrhea (35.6%). 7 Although adenomyosis has always been considered a disease of multiparous women-over 40 years old who have pain and heavy bleeding, diagnosed on hysterectomy, now the epidemiological scenario has completely changed. Over the last decade, adenomyosis has become a condition identified in young women with pain,AUB ,infertility, or no symptoms by using imaging techniques and hysterectomy cannot be the line of treatment .Even available medical management like hormonal therapy is not effective in treating the disease and the complications include infertility, post partum hemorrhage and even endometrial carcinoma in rare cases. As the incidence of adenomyosis is constantly increasing (23.5%), complications are severe and there is no known cure for the condition in modern system of medicine .Ayurveda is having a great scope of research in this field as well as contributing a better solution for the problem. No any previous published scientific research work in academic level has been reported on the ayurvedic management of adenomyosis. So interpreting the condition in ayurvedic view as Mamsa dushti janya garbhashaya vikara, it may be possible to establish aneffective ayurvedic treatment protocol for the managementof adenomyosis and reversing the pathology for getting a permanent cure which is challenge for the ayurveda gynecology practitioners. In view of this Effect of Lekhaniya Mahakashaya Yoga Basti And Apamarga Kshara Taila Uttara Basti Along With Rasanadi Ksheerpaka In The Management Of Adenomyosis- are selected as trial drugs as to provide an easy and cost effective therapeutic measures for adenomyosis. |