| CTRI Number |
CTRI/2025/04/085545 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| 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
|
STUDY TO EVALUATE
THE EFFECTIVENESS OF SWAYAMBHUVA GUGGULU AND SAPTAAMRITA LAUHA
ALONG WITH NIMBA TAILA NASYA IN AKALA PALITYA |
|
Scientific Title of Study
|
A RANDOMIZED DOUBLE ARM COMPARATIVE CLINICAL STUDY TO ASSESS
THE EFFICACY OF SWAYAMBHUVA GUGGULU AND SAPTAAMRITA LAUHA
ALONG WITH NIMBA TAILA PRATIMARSHA NASYA IN AKALA PALITYA VIS-A-VIS
PREMATURE CANITIES |
| 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 Tejashwini D Sathale |
| Designation |
PG Scholar |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital, Hubballi |
| Address |
Department of Kayachkitsa, OPD No. 1, Ayurveda Mahavidyalaya and Hospital, Heggeri Extension, Hubballi-580024
Dharwad
KARNATAKA
580024
India |
| Phone |
7348820043 |
| Fax |
|
| Email |
teja38136@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivaji G Chavan |
| Designation |
Professor and Head of Department Kayachikitsa |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital, Hubballi |
| Address |
Department of Kayachikitsa, OPD No. 1, Ayurveda Mahavidyalaya and Hospital, Heggeri Extension, Hubballi-580024
Dharwad
KARNATAKA
580024
India |
| Phone |
9448335479 |
| Fax |
|
| Email |
shivajichavan1671@gmil.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejashwini D Sathale |
| Designation |
PG Scholar |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital, Hubballi |
| Address |
Department of Kayachikitsa, OPD No. 1, Ayurveda Mahavidyalaya and Hospital, Heggeri Extension, Hubballi-580024
Dharwad
KARNATAKA
580024
India |
| Phone |
7348820043 |
| Fax |
|
| Email |
teja38136@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurveda Mahavidyalaya and Hospital, Heggeri Extension, Hubballi- 580024 |
|
|
Primary Sponsor
|
| Name |
Dr. Tejashwini. D. Sathale |
| Address |
Ayurveda Mahavidyalaya and Hopsital, Heggeri Extension, Hubballi- 580024 |
| 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 Tejashwini Sathale |
Ayurveda Mahavidyalaya and Hospital, Heggeri Extension, Hubballi-580024 |
Department of Kayachikitsa OPD no. 1
Ayurveda Mahavidyalaya Hubballi,Heggeri Extension, Old Hubli- 580024
Kanataka
Dharwad
KARNATAKA |
07348820043
teja38136@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Clearance |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L679||Hair color and hair shaft abnormality, unspecified. Ayurveda Condition: AKALAPALITAH/PALITAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Swayambhuva Guggulu, Reference: Bhavaprakash, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saptaamrita lauha, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimba Taila, Reference: Bhaisajya Ratnavali, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects having classical Signs and Symptoms of Akala Palitya like Kesha
Varna(Colour of hair), Rooksha Sphutita(dry split hair), Snigdha Sthoola(unctuous
thick hair), Daha (burning sensation).
2. Subjects within age group of 18-30 years irrespective of Gender and Occupation.
3. Subjects indicated for Nasya.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with Premature Canities as a part of other conditions such as Vitiligo,
Cutaneous disease involving the scalp and any of the Pre-diagnosed systemic
diseases.
2. Subjects with Pernicious Anaemia and any other Autoimmune diseases.
3. Subjects with Hormonal diseases and Hereditary disorders.
4. History of any hair dyeing within the previous one month.
5. Pregnant and lactating women.
6. Smoking. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To check the parameters as follows
SUBJECTIVE PARAMETERS
Premature change in the color of hair with one of the below symptoms
Dry splitted hair
Oilyness of hair
Burning sensation of scalp
OBJECTIVE PARAMETERS
Graying Severity Score11: The entire Scalp Surface is divided in 5 zones (Frontal, Vertex, Right
and Left Temporal Regions, Occipital). A 1cm2 area showing maximum graying is identified
and marked to count the number of white hair |
Total duration - 60 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To check the parameters as follows
SUBJECTIVE PARAMETERS
Premature change in the color of hair with one of the below symptoms
Dry splitted hair
Oilyness of hair
Burning sensation of scalp
OBJECTIVE PARAMETERS
Graying Severity Score11: The entire Scalp Surface is divided in 5 zones (Frontal, Vertex, Right
and Left Temporal Regions, Occipital). A 1cm2 area showing maximum graying is identified
and marked to count the number of white hair |
1st Follow up - 30th Day
2nd Follow up - 60th Day
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/05/2025 |
| 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="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
|
Present study is a double arm clinical study with Pre-test and Post-test assessment.
Minimum of 50 subjects diagnosed with Akala Palitya fulfilling the diagnostic and inclusion
criteria will be incidentally selected and randomly categorized into two groups as Group A and
Group B each consisting of 25 Subjects for the clinical study excluding the dropouts. Sample Size: 50
Group A: | Sample Size | Minimum of 25 Subjects. | | Amapachana | Shunti Choorna with Ushnaambu. 5gram Twice a Day, Before Food - Till Nirama Lakshana are seen. | | Nasya | Nimba Taila, Pratimarsha nasya (2 drops each nostrils) for 30 days. | | Shamana Aushadhi | Swayambhuva Guggulu with Milk as Anupana. | | Matra | 500 mg, Twice a day, after food for 60 days. |
GROUP B: | Sample Size | Minimum of 25 Subjects. | | Amapachana | Shunti Choorna with Ushnaambu. 5gram Twice a Day, Before Food - Till Nirama Lakshana are seen. | | Nasya | Nimba Taila, Pratimarsha nasya (2 drops each nostrils) for 30 days. | | Shamana Aushadhi | Saptaamrita Lauha with Milk as Anupana. | | Matra | 500 mg, Twice a day, after food for 60 days. |
Follow up:
1. Follow up during the intervention: a. On 0th Day. b. On 30th Day. c. On 60th day 2. Follow up on completion of the intervention:
On 75th day post treatment. PATHYAPATHYA: Subjects of both Groups will be advised Pathya Apathya. |