| CTRI Number |
CTRI/2026/03/105383 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Evaluation of Sukumara Kashayam (Oral) and Brahmi Ghrita Pratimarsh Nasya in the Management of Anovulatory Infertility (Vandhyatva) |
|
Scientific Title of Study
|
A CINICAL STUDY TO EVALUATE THE COMBINED EFFECT OF SUKUMARA KASHAYAM ORALLY & BRAHMI GHRITA PRATIMARSH NASYA IN MANAGEMENT OF VANDHYATVA INFERTILITY DUE TO ANOVULATION |
| 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 Harshada Ashok Kakade |
| Designation |
PG Scholar |
| Affiliation |
Post Graduate Institute of Ayurved Dr S R Rajastan Ayurved University Jodhpur |
| Address |
PG dept of stree roga- prasuti tantra Post Graduate Institute of Ayurved Dr S R Rajastan Ayurved University Jodhpur
342037 Rajastan India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7397995430 |
| Fax |
|
| Email |
harshadakakade99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Neelima |
| Designation |
HOD and Professor of stree roga prasuti tantra |
| Affiliation |
Post Graduate Institute of Ayurved Dr S R Rajastan Ayurved University Jodhpur |
| Address |
PG dept of stree roga prasuti tantra cabin no 63 Post Graduate Institute of Ayurved Dr S R Rajastan Ayurved University JODHPUR
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9610350131 |
| Fax |
|
| Email |
aspneelima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshada Ashok Kakade |
| Designation |
PG Scholar |
| Affiliation |
Post Graduate Institute of Ayurved Dr S R Rajastan Ayurved University Jodhpur |
| Address |
PG dept of stree roga- prasuti tantra Post Graduate Institute of Ayurved Dr S R Rajastan Ayurved University Jodhpur
342037 Rajastan India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7397995430 |
| Fax |
|
| Email |
harshadakakade99@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIA DSRRAU JODHPUR 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved jodhpur |
| Address |
Post Graduate Institute of Ayurved Dr S R Rajastan Ayurved University Jodhpur |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Harshada Ashok Kakade |
Post Graduate Institute of Ayurved Dr S R Rajastan Ayurved University Jodhpur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshada Ashok Kakade |
Post Graduate Institute of Ayurved Jodhpur |
OPD 5 PG dept of stree roga prasuti tantra Post Graduate Institute of Ayurved Dr S R Rajstan Ayurved University Jodhpur 342037
342037 Rajastan India
Jodhpur
RAJASTHAN |
7397995430
harshadakakade99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Post Graduate Institute of Ayurved Jodhpur |
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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sukumara Kashayam , Reference: Sahasrayoga sneha kalpna ghrita & taila kalpna , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Charak Sidhhishana 9 , Procedure details: The participant will be made to lie in supine position with slight neck extension. Lukewarm medicated ghee will be instilled into both nostrils using a sterile dropper. Gentle massage over nose, forehead, cheeks will be done after instillation. The participant will be adviced to inhale gently and spit out any excess secreation.)
(1) Medicine Name: Bramhi Ghrita , Reference: Ashtang hruday uttartantra , Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patiet having complaint of failure to conceive (due to anovulation) within one or more year of regular unprotected coitus.
2.Primary & secondary infertility with anovulation factors |
|
| ExclusionCriteria |
| Details |
1.Infertility due to another factor like uterine factor, cervical factor , tubal factor , peritoneal factor.
2.Patient suffering from chronic diseases like uncontrolled hypertension, diabetes mellitus, thyroid disorder, malignancy, severe anaemia, tuberculosis, etc
3.Patient suffering from hepatitis B, sexually trasmitted diseases, human immunodeficiency virus
4.Congenital anatomical defect of female genital organ leading to vandhyatva.
5.Surgical factors like ovarian tumour, ovarian endometrioma, etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Induction or Restoration of ovulation |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pregnancy |
90 days |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
01/05/2026 |
| 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
|
Infertility due to anovulation is a common cause of female infertility. This study aims to evaluate the combined effect of Sukumara Kashayam orally and Brahmi Ghrita Pratimarsh Nasya in women diagnosed with anovulatory infertility. Sukumara Kashayam will be act as vata anulomana, deepana pachana and stree rogahara .Bramhi Ghrita nasya will directly influences the higher centres responsible for hormonal regulation. The intervention is to restore ovulation , regulate menstrual cycles and improve hormonal balance. Ovulation will be assessed through ultrasonography. Secondary outcomes include conception rate. |