| CTRI Number |
CTRI/2025/04/083832 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study on the Effects of Shatapushpa Taila and Lashuna Taila Nasya in Anovulation |
|
Scientific Title of Study
|
A Comparative Clinical Trial to Evaluate the Efficacy of Shatapushpa Taila and Lashuna Taila Nasya on Abeejotsarga With Special Reference to Anovulation – An Open-Label Randomized Controlled Trial. |
| 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 Hridaynath lad |
| Designation |
PROFESSOR DEPARTMENT OF PRASUTITANTRA EVAM STREEROGA |
| Affiliation |
SHREE SWAMINARAYAN AYURVEDIC MEDICAL COLLEGE |
| Address |
SHREE SWAMINARAYAN AYURVEDIC COLLEGE, KALOL, GANDHINAGAR, GUJARAT.
OPD 001 , DEPARTMENT OF PRASUTITANTRA AND STREE ROGA , KALOL , GANDHINAGAR , GUJARAT
pin : 382721
Gandhinagar
GUJARAT
382721
India |
| Phone |
9822964454 |
| Fax |
|
| Email |
hridaynath.lad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hridaynath lad |
| Designation |
PROFESSOR DEPARTMENT OF PRASUTITANTRA EVAM STREEROGA |
| Affiliation |
SHREE SWAMINARAYAN AYURVEDIC MEDICAL COLLEGE |
| Address |
SHREE SWAMINARAYAN AYURVEDIC COLLEGE, KALOL, GANDHINAGAR, GUJARAT.
OPD 001 , DEPARTMENT OF PRASUTITANTRA AND STREE ROGA , KALOL , GANDHINAGAR , GUJARAT
pin : 382721
Gandhinagar
GUJARAT
382721
India |
| Phone |
9822964454 |
| Fax |
|
| Email |
hridaynath.lad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BAGESHREE GAUSWAMI |
| Designation |
PG SCHOLAR PRASUTITANTRA EVAM STREEROGA |
| Affiliation |
SHREE SWAMINARAYAN AYURVEDIC COLLEGE |
| Address |
SHREE SWAMINARAYAN AYURVEDIC COLLEGE, KALOL, GANDHINAGAR, GUJARAT.
Gandhinagar
GUJARAT
382721
India |
| Phone |
9904659333 |
| Fax |
|
| Email |
gbageshree@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Swaminarayan Ayurvedic College, Kalol, Gandhinagar, Gujarat, Pin Code 382721. |
|
|
Primary Sponsor
|
| Name |
SHREE SWAMINARAYAN AYURVEDIC MEDICAL COLLEGE |
| Address |
Shree Swaminarayan Ayurvedic College, Kalol, Gandhinagar, Gujarat, Pin Code 382721. |
| 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 Hridaynath lad |
Premswarup swami ayurvedic multispeciality hospital |
OPD 001, Department of prasutitantra evam streeroga premswarup Swami ayurvedic multi-speciality Hospital,Ahmedabad-Mehsana Highway AT&po saij Ta. Kalol Dist gandhinagar, gujrat-382721
Gandhinagar
GUJARAT
Gandhinagar
GUJARAT |
98229 64454
hridaynath.lad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee-shree swaminarayan ayurvedic college |
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 | Procedure | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: charaka sutra 5th ch, Procedure details: Procedure details: Performed from the 6th to 12th day of the menstrual cycle. • Time: Morning (Pratahkaal, Abhuktavat) – on an empty stomach. • Dosage: 2 drops of medicated nasal oil in each nostril. • Method: 1. Sit in a comfortable position with the head slightly tilted back. 2. Instill 2 drops of the prescribed nasya oil in each nostril. 3. Inhale deeply to allow the oil to reach the nasal passages. 4. Avoid exposure to cold air or water immediately after.)
(1) Medicine Name: Shatapushpa taila, Reference: kashyapa samhita shatapushpa kalpadhyay, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: charaka sutra 5th ch, Procedure details: Procedure details: Performed from the 6th to 12th day of the menstrual cycle. • Time: Morning (Pratahkaal, Abhuktavat) – on an empty stomach. • Dosage: 2 drops of medicated nasal oil in each nostril. • Method: 1. Sit in a comfortable position with the head slightly tilted back. 2. Instill 2 drops of the prescribed nasya oil in each nostril. 3. Inhale deeply to allow the oil to reach the nasal passages. 4. Avoid exposure to cold air or water immediately after.))
(1) Medicine Name: Lashuna taila, Reference: kashyapa samhita lashuna kalpadhyay, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primary and secondary infertility
Complain of an-ovulatory factors
The patients of child bearing age.
|
|
| ExclusionCriteria |
| Details |
Reproductive tract tuberculosis, carcinoma,
Congenital deformities
Chronic illness,
Cardiac diseases,
Thyroid disorders,
Tubal blockage, uterine factors,
• Patient not suitable for nasya. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Induction of Ovulation: Improvement in follicular development and ovulation as assessed by ultrasonography.
Hormonal Balance: Regulation of LH, FSH, and estrogen-progesterone levels.
Menstrual Regularity: Improvement in cycle length, flow, and reduction of oligomenorrhea/amenorrhea.
|
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in general well-being
Nasya-specific benefits
Enhanced skin glow & lustre
Reduction in headache & sinus congestion
Improved digestion & metabolism
Better sleep & stress reduction |
7 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0"
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
|
Title: “A COMPARATIVE CLINICAL TRIAL TO EVALUATE EFFICACY OF SHATAPUSHPA TAILA AND LASHUNA TAILA NASYA ON ABEEJOTSARGA W.S.R TO AN-OVULATION” – AN OPEN LABEL RANDOMISED CONTROLLED TRIAL. Infertility, particularly an-ovulation, is a significant concern affecting approximately 30% of infertility cases. Ayurveda offers a holistic approach to managing an-ovulation through Nasya therapy. This randomized controlled trial aims to evaluate the efficacy of Shatapushpa Taila Nasya and Lashuna Taila Nasya in promoting ovulation. Shatapushpa (Anethum sowa) is known for its Beejotsarga and Artavajanana properties, aiding in follicular development and hormonal balance. Lashuna (Allium sativum) is described as a potent fertility enhancer that regulates hormonal imbalances and supports oogenesis. Since Nasya (nasal administration) directly influences the brain and hormonal pathways, it is expected to play a vital role in restoring ovulatory functions. This open-label randomized controlled trial will assess the impact of these Ayurvedic interventions on ovulation, providing a cost-effective, safe, and natural alternative for infertility management. Assessment will be done on the basis of subjective and objective criteria and investigations. |