| CTRI Number |
CTRI/2026/01/102436 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of Basti treatment for thin endometrium. |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Mahanarayana Taila Matrabasti and Shatpushpa Taila Matrabasti In Artavakshaya w.s.r To Endometrial Hypoplasia/Thin Endometrium. |
| 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 Navneet |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Department of Prasuti Tantra Evum Stree Roga , Parul Institute of Ayurved , Faculty of Ayurveda, Parul University, Waghodia , Vadodara
Vadodara GUJARAT 391760 India |
| Phone |
9817636102 |
| Fax |
|
| Email |
ahlawatnavneet0509@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Poornima S S |
| Designation |
Professor & HOD |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Department of Prasuti Tantra Evum Stree Roga , Parul Institute of Ayurved , Faculty of Ayurveda, Parul University, Waghodia , Vadodara
Vadodara GUJARAT 391760 India |
| Phone |
9483484430 |
| Fax |
|
| Email |
poornima.karanth42222@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Navneet |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Department of Prasuti Tantra Evum Stree Roga , Parul Institute of Ayurved , Faculty of Ayurveda, Parul University, Waghodia , Vadodara
Vadodara GUJARAT 391760 India |
| Phone |
09817636102 |
| Fax |
|
| Email |
ahlawatnavneet0509@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Navneet PG Scholar Department of Prasuti tantra & Stree roga, Parul Institute of Ayurveda, Parul University P.O Limda , Vadodara Gujarat India 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Navneet |
| Address |
Department of Prasuti tantra & Stree roga, Parul Institute of Ayurveda, Parul University P.O Limda , Vadodara Gujarat India 391760 Edit || Delete
Primary Sponsor |
| Type of Sponsor |
Other [Self] |
|
|
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 Navneet |
Parul Ayurved Hospital |
OPD NO 104 , Department of Prasuti Tantra Evum Stree Roga , Parul Ayurved Hospital , Faculty of Ayurveda, Parul University, Waghodia , Vadodara Vadodara GUJARAT |
9817636102
ahlawatnavneet0509@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIA-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: का० सं० िस० ७/११, Procedure details: Poorva karma- Sthanik abhyanga & swedana
Pradhana karma - 60ml Matra Basti given
Paschata karma-Observe pratyagamana kala) (1) Medicine Name: Mahanarayana Taila, Reference: Bhaishajya Ratanavali 23/343-354, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: का० सं० िस० ७/११, Procedure details: Poorva karma- Sthanik abhyanga & swedana
Pradhana karma - 60ml Matra Basti given
Paschata karma-Observe pratyagamana kala) (1) Medicine Name: Shatpushpa Taila , Reference: Kashyap Samhita 5/9-26, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Age between 15 to 40 years irrespective of marital status.
2 Symptoms of artavkshaya yathochitakala adarshan , alpata, yonivedana (any of two)
3 Duration of menses less than 2 days, Quantity less than 2 pad per day and Spotting menses for previous 2 to 3 consecutive cycles
4 Endometrial thickness less than 7mm at the time of Luteal Phase on day 21 of cycle .
5 Patient is willing to participate in study And Give Written consent for the study.
|
|
| ExclusionCriteria |
| Details |
1 Peri Menopause & Post Menopause women
2 Patients suffering from Thyroid dysfunction, PCOS diabetes mellitus , severe anemia (less than 8gm/Dl) ,Congenital abnormalities of reproductive system
3 Patient on OC Pills.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in Endometrial thickness. |
Total Duration-
BT- 0th Day
DT- 3rd Weeks
AT- 8th Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in menstrual regularity, increase in duration & quantity of menstrual flow, & reduction in associated symptoms such as pelvic pain & backache |
Total Treatment period 2 months
BT-0th Day
DT- 3rd Weeks
AT- 8th Week
|
|
|
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)
|
20/03/2026 |
| 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="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 randomized, comparative, open-label clinical trial designed to evaluate the efficacy of Mahanarayana Taila Matrabasti and Shatpushpa Taila Matrabasti in the management of Artavakshaya with special reference to endometrial hypoplasia/thin endometrium. A total of 40 patients aged 15–40 years, fulfilling diagnostic and inclusion criteria, will be randomly allocated into two groups of 20 each. Group A will receive Mahanarayana Taila Matrabasti and Group B will receive Shatpushpa Taila Matrabasti for 7 days from the 4th day of menstruation for two consecutive cycles. Assessment will be done using subjective menstrual parameters and objective measurement of endometrial thickness. The study duration is 3 months, including follow-up. |