| CTRI Number |
CTRI/2025/11/097401 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yavadi taila Matrabasti and Nasya in vandhyatwa |
|
Scientific Title of Study
|
A clinical study to evaluate efficacy of Yawadi taila nasya and matra basti in vandhyatwa |
| 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 Anushriyam kirti |
| Designation |
M.S. Scholar |
| Affiliation |
Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi |
| Address |
Department of Prasuti Tantra and Stree Roga Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi
Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
7388194991 |
| Fax |
|
| Email |
anushriyamkirti.bhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANJANA SAXENA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Department Of PTSR Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi |
| Address |
Room no-318 Deptt of PTSR Government PG Ayurveda college and hospital Varanasi
Room no-318 Deptt of PTSR Government PG Ayurveda college and hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9839041045 |
| Fax |
|
| Email |
dranjana.saxena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika Gupta |
| Designation |
Assistant professor |
| Affiliation |
Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi |
| Address |
Department of Prasuti Tantra and Stree Roga Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi
Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9839076961 |
| Fax |
|
| Email |
deepikagupta0717@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of PTSR Government Ayurvedic PG College and Hospital Varanasi UP 221002 |
|
|
Primary Sponsor
|
| Name |
Department of Prasuti Tantra Evum Stree Roga government Ayurvedic PG College and Hospital Varanasi |
| Address |
Department of Prasuti Tantra Evum Stree Roga Government Ayurvedic PG College and Hospital Varanasi UP 221002 |
| Type of Sponsor |
Government 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 Anushriyam kirti |
Department Of PTSR Government PG Ayurvedic College and Hospital Varanasi |
Room no-318 Deptt of PTSR Government PG Ayurveda college and hospital Varanasi
Varanasi
UTTAR PRADESH |
7388194991
anushriyamkirti.bhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi,U.P Mahayogi Guru Gorakhnath Ayush University, Gorakhpur, U.P. |
Approved |
| Institutional ethics committee Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi,U.P Mahayogi Guru Gorakhnath Ayush University, Gorakhpur, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: VANDHYA, (2) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: charak siddhi 04/52, Procedure details: Matra basti is always useful for persons emaciated by excess activities, exercise, weight lifting, long way faring, riding vehicles or indulging in sexual intercourse and for person who are weak and afflicted with vatika disorders. While taking matra basti, the person can take food and do the activities as per his liking and can be administered in any season. The dose of matra basti is equal to the minimum dose of oleation therapy. Matra basti promotes strength and can be administered easily. It helps in easy voiding of stool. It causes nourishment and cures diseases caused by aggravated vata.
Matrabasti given through Gudamarga rectal route normalised Apnavayu, leading to Vataanuloman and physiological functioning of Vata, which may help in turn for the extrusion of ovum and sperm in the aggravated Dosha along with Vyana Vayu Tone of the five subtypes of Vata which distributes blood and nutrients to different parts of the body through blood circulation leads to samyak doshas.)
(1) Medicine Name: yawadi tail, Reference: charak chikitsa 28/140-141, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | Matra basti and nasya | (Procedure Reference: charak chikitsa 28/140-141, Procedure details: Procedure Reference: charak siddhi 04/52,Reference: charak chikitsa 28/140-141)
(1) Medicine Name: Yawadi tail, Reference: charak chikitsa 28/140-141, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Married man Being between the ages of 20 and 40; being willing to take part in the study; having a sperm count of 16 million/ml; having a sperm motallity of 15%; and having a sperm volume of 1.5 ml
In all cases of primary and secondary infertility, P. C. O.S., delayed ovulation, at least one fallopian tube must be e patent. married female patient, reproductive age range: 20 to 35 years
|
|
| ExclusionCriteria |
| Details |
Patient without a spouse Ages under 20 and over 40
Congenital and hereditary illnesses
Patient who is single, menopausal, and widowed
Age under 20 but over 35
HIV/VDRL/HbsAg positive; congenital abnormalities; tubular endometriosis; cervical tumor polyp CA cervix uterine fibroid
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To achieve fertility in male and female. |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To achieve fertility with proper implantation. |
3 month |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
22/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
INTERVENTIONAL STUDY Patient having classical features of vandhyatva attending OPD and IPD of Prasuti Tantra and Striroga department of Govt. P.G. Ayurveda College and Hospital chaukaghat Varanasi will be selected randomly for this clinical study. Total 60 couple (120 patients) patients will be selected for the research study. Treatment will continue for 3 consecutive cycles. A GROUP - A. 20 patients are treated with lukewarm YAVWADI TAIL NASYA. B. GROUP -B. 20 patient of group B are treated with lukewarm YAWADI TAIL MATRA BASTI. C. GROUP C. 20 patient of group C are treated with Lukewarm YAVWADI TAIL NASYA WITH MATRA BASTI. To achieve fertility and proper implantation. |