| CTRI Number |
CTRI/2026/01/101829 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Compare the Efficacy of Shatapushpa Thaila Enema and Nasal Instillation with Krishna Tila Kashaya Orally in Scanty Menstruation. |
|
Scientific Title of Study
|
“A Randomized Clinical Study to Compare the Efficacy of Shatapushpa Thaila Matra Basti and Pratimarsha Nasya with Krishna Tila Kwatha Orally in Artavaksaya |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHARON BABU |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda hospital and research centre.Udupi |
| Address |
Department of PG and PhD Studies in Prasootitantra Evam Streeroga opd no 1 and ipd Sri Dharmasthala Manjunatheshwara college of ayurveda hospital and research centre.
Udupi
KARNATAKA
574118
India |
| Phone |
9496562862 |
| Fax |
|
| Email |
sharonbabu2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAMADEVI G |
| Designation |
PROFESSOR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda hospital and research centre.Udupi |
| Address |
Department of PG and PhD Studies in Prasootitantra Evam Streeroga opd no 1 and ipd Sri Dharmasthala Manjunatheshwara college of ayurveda hospital and research centre.
Udupi
KARNATAKA
574118
India |
| Phone |
9449937158 |
| Fax |
|
| Email |
dr.ramadevig@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAMADEVI G |
| Designation |
PROFESSOR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda hospital and research centre.Udupi |
| Address |
Department of PG and PhD Studies in Prasootitantra Evam Streeroga opd no 1 and ipd Sri Dharmasthala Manjunatheshwara college of ayurveda hospital and research centre.
Udupi
KARNATAKA
574118
India |
| Phone |
9449937158 |
| Fax |
|
| Email |
dr.ramadevig@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sharon Babu Pg Scholar Department of PG and PhD stuides in Prasootitantra Evam Streeroga Sri Dharmasthala Manjunatheshwara college of ayurveda hospital and research centre.Udupi 574118 |
|
|
Primary Sponsor
|
| Name |
DR SHARON BABU |
| Address |
Department of PG and PhD stuides in Prasootitantra Evam Streeroga Sri Dharmasthala Manjunatheshwara college of ayurveda hospital and research centre.Udupi 574118 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR RAMADEVI G |
Department of PG and PhD stuides in Prasootitantra Evam Streeroga Sri Dharmasthala Manjunatheshwara college of ayurveda hospital and research centre.Udupi 574118 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHARON BABU |
Sri Dharmasthala Manjunatheshwara college of ayurveda hospital and research centre.Udupi 574118 |
Department of PG and PhD stuides in Prasootitantra Evam Streeroga OPD 1 AND IPD
Udupi
KARNATAKA |
9496562862
sharonbabu2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE-HUMAN SDMCAH&RU |
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: CHARAKA SAMHITHA SIDDHISTHANA, Procedure details: 70 ML GIVEN FOR 7 DAYS AFTER CESSATION OF MENSTRUATION)
(1) Medicine Name: SHATAPUSHPA THAILA, Reference: KASYAPA SAMHITHA, Route: Rectal, Dosage Form: Taila, Dose: 70(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: CHARAKA SAMHITHA SIDDHISTHANA, Procedure details: PRATIMARSHA NASYA 1ML IN EACH NOSTRIL DAILY TWO TIMES MORNING AND EVENING FROM THE DAY OF CESSATION OF MENSES TILL ONSET OF NEXT CYCLE )
(1) Medicine Name: SHATAPUSHPA THAILA, Reference: KASYAPA SAMHITHA, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(ml), Frequency: bd, Duration: 30 Days | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: KRISHNA TILA KWATHA, Reference: YOGA RATNAKARA, Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -GUDA), Additional Information: - | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KRISHNA TILA KWATHA, Reference: YOGA RATNAKARA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -GUDA), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients with reduced flow, using 1 pad per day
Bleeding/spotting less than 2 days
Infrequent menses at greater than 35 days interval |
|
| ExclusionCriteria |
| Details |
Structural abnormalities-fibroids, endometriosis
Patients with uncontrolled systemic illness-DM,HTN
Current use of hormonal contraceptives
Pregnant and lactating woman
Patients diagnosed with STD |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Shatapushpa thaila matra basti and Shatapushpa thaila Pratimarsha nasya in Artavakshaya-menstrual irregularity/scanty menstruation. |
For 1 menstrual cycle
Follow up- next 2 menstrual cycles
Total study duration-3 menstrual cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the combined effect of Krishna Tila kwatha along with Matrabasti/Pratimarsha nasya. |
For 1 menstrual cycle
Follow up- next 2 menstrual cycles
Total study duration-3 menstrual cycles |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/03/2026 |
| 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="0"
Months="11"
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
|
In todays fast moving lifestyle gynaecological problems are increasing day by day.The commonest one is Artava kshaya.We can compared it with Oligomenorrhea and Hypomenorrhea .Among all menstrual disorders ,oligomenorrhea is one that affects 13.5% of the general population.4-10% of oligomenorrhea in women of reproductive age (puberty to menopause) is caused by polycystic ovarian disease. |