| CTRI Number |
CTRI/2025/02/079916 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of ovulation failure and irregular intervals of menstrual cycle |
|
Scientific Title of Study
|
An open label randomized comparative clinical trial to evaluate the efficacy of Nasya with Kshirbala Taila (101 Avarthi ) and Mahanarayana Taila in 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 Mona Rani |
| Designation |
PG Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and hospital sector 46 B Chandigarh |
| Address |
Room No. - A-205, Shri Dhanwantry Ayurvedic College and hospital sector 46 B Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9872799576 |
| Fax |
|
| Email |
drmona0705@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha Maganti |
| Designation |
Associate Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic College and hospital sector 46 B Chandigarh |
| Address |
Room No. - A-205, Shri Dhanwantry Ayurvedic College and hospital sector 46 B Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9043940396 |
| Fax |
|
| Email |
dranuradha98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuradha Maganti |
| Designation |
Associate Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic College and hospital sector 46 B Chandigarh |
| Address |
Room No. - A-205, Shri Dhanwantry Ayurvedic College and hospital sector 46 B Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9043940396 |
| Fax |
|
| Email |
dranuradha98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dhanwantry Ayurvedic College and Hospital sector 46 B Chandigarh |
|
|
Primary Sponsor
|
| Name |
Dr Mona Rani |
| Address |
Shri Dhanwantry Ayurvedic College and Hospital sector 46 B Chandigarh,India |
| Type of Sponsor |
Other [Private Ayurvedic 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 Mona Rani |
Shri Dhanwantry Ayurvedic College and hospital sector 46 B Chandigarh |
ROOM NO 105,First Floor, Department of Prasuti Tantra Evum Stree Roga Chandigarh
Chandigarh
CHANDIGARH |
9872799576
drmona0705@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Dhanwantry Ayurvedic College and Hospital sector 46 B Chandigarh |
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 | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Charaka Samhita Siddhi sthana adhyaya 09 shloka no. 98-103, Procedure details: patient lied in supine position with head and neck low position; instil 8 drops of oil in each nostril. Pinch the nose once and after releasing, suck the oil up. Spit the oil when it reaches the throat. )
(1) Medicine Name: Kshirbala Taila (101 Avarathi), Reference: ashtang hridyam chikitsa 22/45-46, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 14 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Charaka samhita siddhi sthana adhyaya 09 shloka no. 98-103, Procedure details: Patient lies down in supine position with head and neck low position; instil 8 drops of oil in each nostril. Pinch the nose once and after releasing, suck the oil up. Spit the oil when it reaches the throat. )
(1) Medicine Name: Mahanarayana Taila , Reference: Bhaishajya Ratnavali adhyaya 26 shloka no. 343 -354, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Married female subjects of age group between 18 to 40 years.Subjects with full consent for participation in the clinical trial.Subjects with history of regular cycle (24 to 38 days) and irregular cycle more than 38-90 days fulfilling diagnostic criteria
|
|
| ExclusionCriteria |
| Details |
•Hyperthyroidism, uncontrolled hypothyroidism •Subjects on hormone (estrogen & progesterone) pills •Subjects on ovulation induction •Subjects having history of diabetes mellitus, hypertension
•Subjects with congenital disease •Subjects having any pelvic pathologies like uterine fibroid, adenomyosis, endometriosis, pelvic inflammatory diseases •Ovarian tumors •Hyperprolactinemia with serum prolactin more than 50ng/ml •Obesity with BMI more than 30
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ovulation |
baseline to 3rd menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Menstraul cycle regularity |
baseline to 90th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="3"
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
|
Anovulation is the
failure to release an oocyte from a mature Graafian follicle. Anovulation is one of
common causes of infertility. The hypothalamic-pituitary-ovarian axis
disturbance can be responsible for anovulation. This trial is to evaluate and compare the effect of Nasya with Kshirbala Taila (101 Avarthi) and Mahanarayana Taila in managing annovulation and irregular intervals of menstrual cycle. The trial will be performed in two groups consisting of 30 patients in each group. One group will be given Nasya with Kshirbala Taila (101 Avarthi) and the second group will be given nasya with Mahanarayana Taila. The dose for Nasya in both groups will be 8 drops per day in each nostril for 7days after cessation of menses , then following break of 3 days , again Nasya is to be taken for 7 days in same dose. The primary expected outcome will be ovulation whereas secondary expected outcome will be menstrual cycle regularity. |