| CTRI Number |
CTRI/2023/11/059719 [Registered on: 09/11/2023] Trial Registered Prospectively |
| Last Modified On: |
08/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to evaluate the combined effect of Dashamoola ksheera basti and Rakta Chandana Yoga oral administration in Vandhyatwa w.s.r.to female infertility. |
|
Scientific Title of Study
|
An open label single arm Clinical study to evaluate the combined effect of Dashamoola ksheera basti and Rakta Chandana Yoga oral administration in Vandhyatwa w.s.r.to female infertility. |
| 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 P Deepika Bhat |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi University |
| Address |
OPD 1
Department of Prasooti Tantra and Streeroga
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8660819737 |
| Fax |
|
| Email |
pdeepikabhat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAMATHA KV |
| Designation |
Proffessor and Principal |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA, KUTHPADY UDUPI |
| Address |
Department of PG studies in Prasuti Tantra and Stree Roga Sri
Dharmasthala Manjunatheshwara college of Ayurveda And Hospital
Kuthpady Udupi
Udupi
KARNATAKA
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
9448215605 |
| Fax |
|
| Email |
mamath2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MAMATHA KV |
| Designation |
Proffessor and Principal |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA, KUTHPADY UDUPI |
| Address |
Department of PG studies in Prasuti Tantra and Stree Roga Sri
Dharmasthala Manjunatheshwara college of Ayurveda And Hospital
Kuthpady Udupi
Udupi
KARNATAKA
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
9448215605 |
| Fax |
|
| Email |
mamath2@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD 1
Department of Prasooti Tantra and Streeroga
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Udupi
574118 |
|
|
Primary Sponsor
|
| Name |
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Udupi |
| Address |
OPD 1
Department of Prasooti Tantra and Streeroga
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Udupi
574118 |
| Type of Sponsor |
Private medical college |
|
|
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 P Deepika bhat |
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Udupi |
OPD 1
Department of PG Studies Prasooti Tantra and Streeroga
Udupi
KARNATAKA |
8660819737
pdeepikabhat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Udupi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R399||Unspecified symptoms and signs involving the genitourinary system. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoga-bastiH, योग-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Ashtanga hridaya Sutra Sthana 19 th Chapter 64 and 65 Shloka, Procedure details: Dashamoola ksheera basti and Sahacharadi taila Anuvasana basti in Yoga basti course,
after cessation of menstrual bleeding for 2 consecutive menstrual cycles
Dashamoola Ksheera Basti will be administered in the dosage of 480 ml in Yoga Basti
course, where, three Basti will be administered on 2nd,4th and 6th day in the morning on an
empty stomach
• Five Anuvasana Basti with Sahacharadi Taila 60 ml will be administered on 1st, 3rd,5th,7th
and 8th day in the afternoon, immediately after )
(1) Medicine Name: Dashamoola ksheera basti and Sahacharadi taila Anuvasana basti , Reference: CharakaSamhitha,Chikitsasthana;chapter 30, Verse 111, CharakaSamhitha, Chikitsasthana Chapter 21, Verse 69. , Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 8 Days |
|
|
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Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient who is in active marital life with partner having normal seminogram.
2. Patients who are fit for basti.
3. Patients with PCOD.
4. Patients with Unexplained Infertility.
5. Patients with Endometriosis and Adenomyosis.
6. Patients with Chocolate cyst/Ovarian cyst measuring less than 4 cms.
7. Patients presenting with Dysfunctional Uterine Bleedin |
|
| ExclusionCriteria |
| Details |
1. Patients with Genital infections.
2. Patients with Bad obstetric history (Previous unfavorable fetal outcome in terms
of 2 or more consecutive spontaneous abortions, early neonatal deaths, etc.)
3. Patients with premature ovarian failure.
4. Patients with Congenital anomalies of uterus.
5. Patients with surgical factors including uterine fibroids, cervical polyp, pin hole
cervical os etc.
6. Patients suffering from genital tuberculosis.
7. Patients with hydrosalpinx and tubal block.
8. Patients with Sexually Transmitted Diseases such as HIV and HBsAg.
9. Any other systemic illness such as DM, HTN, Thyroid dysfunctio |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Conception evidenced by UPT and USG. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Attainment of Shuddha Artava Lakshana |
1 month (will be assessed on next/following menstrual cycle) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/12/2023 |
| 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="1"
Months="0"
Days="0" |
|
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 classics, Vandhyatwa is seen as a condition which occurs as a complication of untreated Yonivyapat, Artavavyapat and Asrigdhara. Vandhyatwa is one among the 80 Vataja Nanatmaja Vikaras.Vata is mandatorily involved in the pathology of all the Yonivyapat and Artavavyapat. Basti, being Ardha Chikitsa which is said to be Paramaushadha for treatmentbof Vata disorders,tackles all the gynecological pathologies of Vata including Vandhyatwa. Sahacharadi Taila is selected for Anuvasna Basti. As Sahachara is a potent Vatahara drug and Taila does Yoni Vishodhana. Dashamoola is best Vata kaphahara. Ksheera is Amritopama. When Dashamoola is processed with ksheera, it acts best on Tridosha.Dashamoola Ksheera Niruha Basti is thus preferred. Raktachandana is Vrishya and Apamarga is Vatahara. So, in this clinical trial oral administration of Raktachandana with ApamargaSwarasa has been taken, which is successfully practiced by the folklore practicionors. So, aiming at finding out the best method of treatment for Infertility, this study istaken up to evaluate the combined effect of Dashamoola Ksheera Niruha Basti and Rakthachandana Yoga oral administration in female Infertility
Patient will be evaluated before (0th day), at the end of the second course of Basti and oral medication and on the day of follow up, based on subjective and objective parameters. SUBJECTIVE PARAMETERS: Attainment of Suddha Artava Lakshanas OBJECTIVE PARAMETERS: Conception evidenced by UPT and USG. • Conceived • not conceived |