| CTRI Number |
CTRI/2025/12/099695 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| 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
|
A clinical study to assess the effect of Vamshapatra kwatha in women having delayed and scanty menstrual periods |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study to evaluate the efficacy of Vamshapatra Kwatha in Artavakshaya |
| 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 Kavya M Rao |
| Designation |
MS (Ayu) Scholar - Prasuti tantra Stree roga |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Department of Prasuti tantra Stree roga
Alvas Ayurveda Medical College, Vidyagiri , Moodubidre
Dakshina Kannada District
Karnataka 574227
Department of Prasuti tantra Stree roga
Alvas Ayurveda Medical College, Vidyagiri , Moodubidre
Dakshina Kannada District
Karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9448420498 |
| Fax |
|
| Email |
kavya31031998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumarani Rajesh |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Department of Prasuti tantra Stree roga
Alvas Ayurveda Medical College, Vidyagiri , Moodubidre
Dakshina Kannada District
Karnataka 574227
Department of Prasuti tantra Stree roga
Alvas Ayurveda Medical College, Vidyagiri , Moodubidre
Dakshina Kannada District
Karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9449664617 |
| Fax |
|
| Email |
drsumaranirajesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavya M Rao |
| Designation |
MS (Ayu) Scholar - Prasuti tantra Stree roga |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Department of Prasuti tantra Stree roga
Alvas Ayurveda Medical College, Vidyagiri , Moodubidre
Dakshina Kannada District
Karnataka 574227
Department of Prasuti tantra Stree roga
Alvas Ayurveda Medical College, Vidyagiri , Moodubidre
Dakshina Kannada District
Karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9448420498 |
| Fax |
|
| Email |
kavya31031998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prasuti Tantra Stree roga
Alvas Ayurveda Medical College, Vidyagiri , Moodubidre
Dakshina Kannada District
Karnataka 574227 |
|
|
Primary Sponsor
|
| Name |
Dr Kavya M Rao |
| Address |
Alvas Ayurveda Medical College, Vidyagiri , Moodubidre
Dakshina Kannada District
Karnataka 574227 |
| 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 Kavya M Rao |
Alvas Ayurveda Medical College |
Department of Prasuti Tantra Streeroga
3rd Floor
Alvas Ayurveda Medical College, Vidyagiri , Moodubidre, Dakshina Kannada - 574227
Dakshina Kannada
KARNATAKA |
9448420498
kavya31031998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Alvas Ayurveda Medical College |
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 | Drug | Classical | | (1) Medicine Name: Vamshapatra Kwatha, Reference: Adarsha Nighantu Uttararda under Trunadivarga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 35 Days, anupAna/sahapAna: Yes(details: -Guda), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Krishna Tila Kwatha , Reference: Yogaratnakara under Yonivyapad chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 35 Days, anupAna/sahapAna: Yes(details: -Guda), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Women aged between 16 to 35 years
Patients with history of artavakshaya in atleast 2 previous cycle
Yathochitakala adarshanam of artava the interval between 2 cycles exceeds more than 35 days
Haemoglobin greater than 11 gm per dl |
|
| ExclusionCriteria |
| Details |
Patients suffering from any systemic diseases
Pregnant woman and lactating mother
Known case of HIV and HBsAg positive
Endometrial or cervical or breast carcinoma or any malignant diseases
Thyroid disorders
Female using oral contraceptives IUCD injectable contraceptives
Any congenital anomalies |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Interval between the cycles and duration of bleeding and
amount of bleeding |
Interval between the cycles and duration of bleeding and
amount of bleeding assessed at baseline and after completion of treatment of 8 weeks and during the third menstrual cycle follow up without medication
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in amount of bleeding, cycle regularisation |
Assessed at baseline,4 weeks, 8 weeks |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
03/01/2026 |
| 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="7"
Days="15" |
|
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
|
Normal menstruation is an essential physiological function of women during their reproductive age and is indicator of healthy reproductive organ. Artavakshaya is when there is scanty bleeding or when the menstrual bleeding occurs more than 35 days apart and which remains constant at that frequency.In Adarsha Nighantu Uttararda under Trunadivarga Vamshapatra kwatha mentioned as Artavajanaka will be brought under trial in comparison with krishnatila kwatha which is proved to be effective in artavakshaya. It has the drug which contains artavajanana shotaghna raktavikara nashana actions. After fulfilling the assessment criteria, subjects will be divided into 2 groups and the intervention will be given. The intervention group will be given Vamshapatra kwatha and the comparative group will be given Krishna tila kwatha. The treatment period will be 2 consecutive cycles, assessment will be done on the 5th day of each cycle during the treatment and follow up will be done on 5th day of cycle. Hypothesis of this study H0 there is neither statistically significant difference between Vamshapatra kwatha and Krishnatila kwatha nor vamshapatra kwatha is better than Krishnatila kwatha in Artavakshaya H1 there is statistically significant difference between Vamshapatra kwatha and Krishnatila kwatha with Vamshapatra kwatha showing better effect than Krishnatila kwatha in Artavakshaya |