| CTRI Number |
CTRI/2025/09/095222 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of uttar basti using lashunadi taila in female infertility (Fallopian tubal blockage) in 30 participants |
|
Scientific Title of Study
|
Clinical Evaluation of Lashunadi Taila Uttar Basti in Vandhyatva (fallopian tubal blockage) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepika yadav |
| Designation |
MD Scholar |
| Affiliation |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan, haridwar |
| Address |
Department of Panchkarma, OPD no - 4, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali Yogpeeth Phase 1, Haridwar, Uttarakhand
Department of Panchkarma, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali Yogpeeth, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
09675072776 |
| Fax |
|
| Email |
deepikay100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Mahajan |
| Designation |
Professor |
| Affiliation |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan, haridwar |
| Address |
Department of Panchkarma, OPD no - 4, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali Yogpeeth, Phase 1, Haridwar, Uttarakhand
Department of Panchkarma, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali Yogpeeth, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9760376761 |
| Fax |
|
| Email |
drshivani84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepika Yadav |
| Designation |
MD Scholar |
| Affiliation |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan, haridwar |
| Address |
Department of Panchkarma, OPD no - 4, 23, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali Yogpeeth, Phase 1, Haridwar, Uttarakhand
Department of Panchkarma, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali Yogpeeth, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
09675072776 |
| Fax |
|
| Email |
deepikay100@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali Yogpeeth, Haridwar, India. pincode - 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand India Pincode 249405 |
| 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 |
| Deepika Yadav |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
Department of Panchkarma, OPD no 4, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Pincode 249405
Hardwar
UTTARANCHAL |
9675072776
deepikay100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patanjali Ayurved College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N971||Female infertility of tubal origin. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: charak siddhi 9/62, Procedure details: POORVA KARMA
•Poorva karma in three steps after cessation of menses- One day before patients will be admitted in the hospital. In the morning following steps will be carried out after emptying rectum & bladder.
•Abhyanga (massage): Luke warm Bala Taila for 10 minutes on abdomen and back
•Swedana (hot fomentation): Nadi Swedana with Dashmoola kwatha for 10 minutes on lower abdomen and back
•Yoni Prakshalana (Vaginal Douche): with decoction Triphala kwatha
•The private part shall be shaved and cleaned with antiseptic solution (Savlon/dettol).
PRADHAN KARMA
•Instruments required- Sim’s double bladed vaginal speculum, anterior vaginal wall retractor, alli’s forceps, uterine sound, sponge holding forcep & Uttar basti cannula fitted with disposable syringe, Pichu.
•The whole procedure will be carried out in the Operation Theatre (OT) in fully aseptic care.
•The medicated oil and instruments will be autoclaved before procedure.
•The patient will be examined for the parameters like BP, Pulse, temperature before and after the procedure.
•Patient will lie down on operation table in lithotomy position with the part exposed, cleaned and draped.
•5 ml medicated oil (trial drugs) filled in fresh disposable syringe and to be attached with Uttar basti canula. Air will be expelled from the canula before administration.
•Vagina and cervix will be properly visualized with the help of Sim’s double bladed vaginal speculum and anterior vaginal wall retractor.
•The anterior lip of cervix will be caught with the help of Allis forceps.
•Then uterine sounding will be done to know the position of uterus and patency of internal os.
•After giving head low position to patient, Uttar basti cannula, shall be inserted into uterine cavity through cervix and autoclaved medicated oil to be pushed slowly with steady hands then a Pichu had kept in vagina. All instruments shall be removed.
PASCHAT KARMA
•The patient will be shifted to bed and head low position was maintained for 2 hours for better absorption of drug and lower abdomen will be fomented with hot water bag for Swedana purpose.
•The Pichu (tampon) shall be removed after 2 hours of procedure before micturition.
)
(1) Medicine Name: Lashunadi taila, Reference: kashyap kalpa lashunkalpa 93-97, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 3 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Diagnosed with fallopian tubal blockage (unilateral or bilateral) on the basis of hysterosalpingogram (HSG)
2. Fit for Garbhashaya - gata Uttarabasti.
3. ready to sign the informed consent form and follow the treatment protocol |
|
| ExclusionCriteria |
| Details |
1. Acute pelvic infection
2. Endometriosis
3. Hypersensitivity to chemical dye
4. congenital anomalies of vulva and vagina
5. Carcinoma cervix
6. Sexually transmitted diseases
7. Any infective condition like tuberculosis.
8. Tubal blockage with hydrosalpinx |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tubal potency (through hysterosalpingogram) |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NONE |
NONE |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="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
|
This study is a Role of Uttara Basti in Vandhyatva (fallopian tubal blockage). This will be conducted on 30 selected patients from OPD/IPD of Panchkarma department of Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar. Uttara Basti will be administered with Lashunadi taila for 3 days. Follow up will be taken after 1 month and Uttara basti will be given for 3 more consecutive months. Assessment will be done on the basis of HSG. |